Registration Dossier
Registration Dossier
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EC number: 232-401-3 | CAS number: 8016-11-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Studies of skin and eye irritation in vivo are available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Very little information provided on the materials and methods of the study. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Not stated
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No details
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- The test material was applied undiluted to the belly of the rabbits and left uncovered
- Duration of treatment / exposure:
- Not stated
- Observation period:
- Not stated
- Number of animals:
- Not stated
- Details on study design:
- No details provided for exposure of rabbits for the assessment of skin irritation. The results tabulation indicates open application to the belly of rabbits but does not detail the number of animals, preparation of the test site, means or duration of application. The method of assessing reactions is also not specified
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: No data
- Score:
- 2
- Reversibility:
- no data
- Remarks on result:
- other: The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2. No details of the method of assessment are given and no means of correlating the result with erythema or oedema reactions.
- Irritant / corrosive response data:
- The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2. No details of the method of assessment are given and no means of correlating the result with erythema or oedema reactions.
- Other effects:
- No data
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- riteria Criteria used for interpretation of results: not specified
- Conclusions:
- Irritation
The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2. - Executive summary:
Read across to ESBO results are justified for ELO on basis of similar function and structure. The suporting information relating to in vivo irritation reported in this study is applied to ELO.
Carcinogenic and acute toxicity potential of the test material was assayed.
Irritation
The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.
Toxicity
A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.
Carcinogenicity
The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.
Sebaceous Gland Suppression
The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.
The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 10 August 1981 to 17 August 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The experimental design is similar to that of OECD guideline 404 with enhanced exposure due to an extended exposure period - 24 hours - and inclusion of dermal abrasion prior to application of the test material. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) S 163.81-5 "Primary dermal irritation study" Federal Register, Vol. 43, No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- Exposure period was for 24 hours rather than 4 hours as currently required for assessment of irritation
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the laboratory premises. They weighed 2 - 3 Kgs.
They were housed individually in metal cages numbered by ear tags.
They were kept at constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 12-hours light cycle day.
The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water.
Prior to treatment they were adapted to the laboratory for a minimum of 4 days. - Type of coverage:
- occlusive
- Preparation of test site:
- other: skin was shaved. One site abraded one left unabraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abraded and intact skin.
The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. - Duration of treatment / exposure:
- The dressings were removed after a 24 hour application.
- Observation period:
- The skin reaction was appraised using standard Draize assessment, on removal of dressing and during an observation period of 7 days.
- Number of animals:
- 3 male and 3 female adult New Zealand White rabbits
- Details on study design:
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaved skin on one side was lightly sacrified using a scalpel blade.
Gauze patches of 2.5 x 2.5 cm laden with 0.5 mL of the test material were applied to the prepared abraded and intact skin. The patches were covereed with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
The skin reaction was appraised on ths basis of the following evaluation scheme:
Score for skin irritation in rabbits:
Erythema and eschar formation:
No erythema: .................................................................... 0
Very slight erythema (barely perceptible):.................... 1
Well defined erythema:..................................................... 2
Moderate to severe erythema:........................................ 3
Severe erythema (beet redness) to slight eschar
formation {injuries in depth) :......................................... 4
Total possible erythema score:...................................... 4
Oedema formation
No edema: .......................................................................0
Very sllght edema (barely perceptible): ..................... 1
Sllght edema (edges of area well defined by
definite raising):............................................................. 2
Moderate edema (raised approximately 1 mm): ...... 3
Severe edema {raised more than 1 mm and
extending beyond area of exposure): ........................4
Total possible oedema score: ........................................ 4 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h post application
- Max. score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Only limited information is provided relating to 24 and 72 scores. Reversibility is presented graphically
- Irritant / corrosive response data:
- The results of the primary skin irritation test are reported in Table 1.
Tha calculated primary irritation index was 2.6 - this includes results from abraded and non-abraded skin.
TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin, according to the interpretation of PII results
After 24 hours the surface of the erythema was greater than the site of application on all sites except No. 415 (intact) and No. 416 (abraded). This observation was made after 48 hours on both sites of animal No. 417 and after 72 hours on the abraded side of the same animal.
Results were revaluated to determine a possble classification in accordance with EU/GHS criteria.
In the absence of individual animal scores, taking into account the extended exposure period and assuming a linear response for ameliorating dermal responses between 24 and 72 hours, the mean results for non-abraded skin were averaged for 24 and 72 hour responses as an approximation of the Draize result. On this basis, the mean erythema score for non-abraded skin over 24-72 h was 1.5 and for oedema the mean result was 0.75.
Neiher of these values exceeds the EU classification threshold. - Other effects:
- With the exception of the last day of the test, a slight sedation was observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of the present experiment TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin.
The calculated primary irritation index was 2.6, based on a combined assessment of abraded and non-abraded skin exposed for 24 hours.
The abraded skin results are not appropriate for assessment under EU classification guidelines. The mean scores are 24 and 72 hours were used as approximations to the 24 -72h mean. Erythema and oedema mean scores were approximated to be 1.5 and 0.75 respectively. Neither results exceeds the EU classification threshold. It is quite likely that the reactions observed were exacerbated by the prolonged exposure and so the estimated mean values are conservative estimates of irritating potential. - Executive summary:
Under the condition of the present experiment TK 11'278 was found to cause a moderate irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 2.6. The estimation of the mean score for irritation based on the 24 and 72 hour assessments was circa 1.0. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Referenceopen allclose all
Toxicity
A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.
Carcinogenicity
The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.
Sebaceous Gland Suppression
The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.
The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.
Table 1 Calculation of the primary skin irritation index
Time after exposure (hours) |
Mean Reaction Score |
|||
Erythema |
Oedema |
|||
Intact Skin |
Abraded Skin |
Intact Skin |
Abraded Skin |
|
24 |
1.7 |
2.0 |
1.0 |
1.5 |
72 |
1.3 |
1.5 |
0.5 |
0.7 |
|
||||
Total |
3.0 |
3.5 |
1.5 |
2.2 |
Assessment of Irritation
0
0.1 - 1.0 = minimal
1.1 - 2.0 = slight
2.1 - 4.0 = moderate
4.1 - 6.0 = marked
6.1 - 8.0 = extreme
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. The primary irritation index was 2.6.
The abraded skin results are not appropriate for assessment under EU classification guidelines. The mean scores are 24 and 72 hours were used as approximations to the 24 -72h mean. Erythema and oedema mean scores were approximated to be 1.5 and 0.75 respectively. Neither results exceeds the EU classification threshold
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 10 August 1981 - 24 August 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.is study meets the criteria laid out in OECD Guideline 405.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Procedure used was that described in the Proposed Guideline of the United States Environmental Protection Agency (EPA) S 163.81 - 4 "Primary eye irritation study", Federal Register Vol. 43, No. 163, August 2, 1978 that were in draft at time of study conduct and subsequently adopted.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The test was performed on 3 male and 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at constant room temperature of 22 ± 2°C, at a relative humidity of 55 ± 10% and on a 12 hour light cycle day. The animals had ad libitum access to standard rabbit food and water.
Prior to treatment they were adapted to the laboratory for a minimum of 4 days. Only rabbits with normal opthalmic findings were used for these tests - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each rabbit served as the inherent control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 9 - three rinsed and six not rinsed after installation
- Details on study design:
- 0.1 mL of undiluted test material was instilled into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In three of the nine rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, 7, 10 and 14 and was scored for each individual rabbit.
As the test compound is not soluble in water, an assessment of pH was not performed prior to dosing. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- Kay and Callendra system
- Time point:
- other: 24 hours
- Score:
- 4.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- Kay and Callendra system
- Time point:
- other: 24 hours
- Score:
- 3.3
- Max. score:
- 20
- Reversibility:
- other: after 7 days only one of the three animals had slight conjunctival redness
- Irritant / corrosive response data:
- The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours.
On this basis the mean results for the rinsed eyes (scores for six rabbits) were -
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 1.06
Conjunctival swelling/chemosis = 0.61
and for the rinsed eyes the mean values for 24-72 hours were:
corneal opacity = 0.0
Iris response = 0.0
Conjunctival redness = 0.89
Conjunctival swelling/chemosis = 0.56.
No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7. - Other effects:
- No symptoms of systemic intoxication were observed throughout the whole test period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiement, the test material was found to cause slight conjunctival irritiation when applied to the rabbit eye mucosa:
Unrinsed eyes:
No irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean acore of 4.7 after 24 hours. After 10 days all irritation had disappeared.
Rinsed eyes:
No irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. No symptoms of systemic intoxication were observed throughout the whole test period. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted. - Executive summary:
The test was performed on three male and six female New Zealand White rabbits. The test material was found to cause the following irritiation when applied to the rabbit eye mucosa: In the unrinsed eyes no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean acore of 4.7 after 24 hours. After 10 days all irritation had disappeared. In the rinsed eyes, no irritation of cornea and iris was observed at any reading. Irritation was seen only in the conjunctiva with a maximum mean score of 3.3 after 24 hours. After 7 days onwards only one of the three animals had a slight conjunctival redness. No symptoms of systemic intoxication were observed throughout the whole test period.
Reactions were re-assessed using EU classification criteria and responses were confirmed as not exceeding the EU thresholds for triggering classification of an ocular irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Very little information provided on the materials and methods of the study. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No information provided to determine methods used to assess ocular irritation - the results indicate that only corneal injury was assessed and other parameters normally included in current guidelines (e.g. iris and conjunctival responses) were not assessed.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data supplied
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- No details are provided to determine how rabbit ocular injury was assessed. No methodological information was available.
- Duration of treatment / exposure:
- No details for duration of exposure
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- No data
- Details on study design:
- No details supplied in report publication
- Irritation parameter:
- cornea opacity score
- Basis:
- other: the basis for the ocular score is not stated in publication
- Time point:
- other: No details provided
- Score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- other: The value for ocular injury cannot be interpreted since no details are provided for its derivation
- Irritant / corrosive response data:
- Corneal injury score of 1 recorded
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The indication is that some degree of corneal injury was induced by instillation of soybean oil, epoxidised. However, the 60 comparative materials listed in this report had scores in the range of 0-10 indicating the corneal injury induced by ESBO is slight or minimal.
- Executive summary:
Carcinogenic and acute toxicity potential of teh test material was assayed.
Irritation
The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.
Toxicity
A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.
Carcinogenicity
The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.
Sebaceous Gland Suppression
The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.
The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.
Sensitisation:
Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy materials. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.
It was concluded that the test material was not sensitising.
Referenceopen allclose all
Table: 1 Calculation of the primary eye irritation index
Time after exposure days |
Mean reaction score |
|||||
Unrinsed eyes (A) |
Rinsed eyes (B) |
|||||
Cornea |
iris |
conjunctiva |
cornea |
iris |
conjunctiva |
|
1 |
0 |
0 |
4.7 |
0 |
0 |
3.3 |
2 |
0 |
0 |
3.3 |
0 |
0 |
2.7 |
3 |
0 |
0 |
2 |
0 |
0 |
2.7 |
4 |
0 |
0 |
1.3 |
0 |
0 |
1.3 |
7 |
0 |
0 |
1 |
0 |
0 |
0.7 |
10 |
0 |
0 |
0 |
0 |
0 |
0.7 |
14 |
0 |
0 |
0 |
0 |
0 |
0.7 |
The ocular reactions were assessed by the Kay and Callendra system, from which a PII was derived. For classification purposes the results were re-calculated using a standard Draize score deriving a mean for the reactions over 24-72 hours. On this basis the mean results for the rinsed eyes (scores for six rabbits) were - corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 1.06 Conjunctival swelling/chemosis = 0.61 and for the rinsed eyes the mean values for 24-72 hours were: corneal opacity = 0.0 Iris response = 0.0 Conjunctival redness = 0.89 Conjunctival swelling/chemosis = 0.56. No corneal or iridial changes were evident for any of the nine rabbits. Conjunctival irritation did not exceed diffuse crimson coloration and had resolved in all unrinsed rabbits by Day 10. reactions persisted for one of the rinsed eyes to Day 14. Conjunctival chemosis had largely resolved by Day 4 for all nine rabbits although slight reactions persisted for one, unrinsed, eye to Day 7.
Toxicity
A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.
Carcinogenicity
The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.
Sebaceous Gland Suppression
The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.
The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
Justification for classification or non-classification
Classification for skin and eye irritation is not indicated by the results of the available studies.
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