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EC number: 281-866-9 | CAS number: 84045-65-8
- 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
FAT 40147 is neither a skin nor an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- Company code: FAT 40'147/E
Batch No.: EN 94'066.32
Appearance: powder
Purity: 83.3 %
Stability of the test Compound: until October 1988
pH-value: 7.9 (1 g/L water) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Number and sex of animals used: 3 females
- Initial age: 12 - 14 weeks
- Initial body weight range: 2020-2410 g
- Individual identification: numbered ear tags; The cages were marked with sex, animal No., GU-Project No. and the company code of the test article.
- Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20±3° C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
- Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
- Euthanasia: At the end of the observation period, the animals were sacrificed by intravenous injection of hypnotic T61 (Hoechst). - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- - Application of the Substance:
A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water
moistened before application. Exposure duration was 4 hours.
- Study evaluation:
- Scoring of symptoms and local reactions: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following
observation period.
- Mode of calculation: The index of primary cutaneous irritation was calculated as follows:
- the scores obtained for erythema and oedema at 1 hour, 24, 48 and 72 hours after removal of the patch, on the 3 rabbits examined, are summed up
- the sums of total oedema and erythema were divided by 12, when all the animals survived.
- the score obtained is defined as the "index of primary cutaneous irritation".
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
- Body weight: at beginning of acclimatization and end of test.
- Mortality: daily a.m.and p.m., once daily on weekends and holidays.
Interpretation of the primary-irritation index:
< 0.5 : non irritant
0.6 - 3.0 : slightly irritant
3.1 - 5.0 : irritant
5.1 - 8.0 : severely irritant - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- other: Due to intensive staining by the test substance a scoring of the erythema values at 24 hours was not possible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: INDEX of skin irritation
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h
- Score:
- 0.17
- Max. score:
- 8
- Irritant / corrosive response data:
- Due to intensive red staining by the test substance a scoring of the erythema values was not possible.
The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. - Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40147/E can be considered as not a skin irritant.
- Executive summary:
The skin irritation potential of the test substance was evaluated according to OECD Guideline 404. The test was performed on 3 female adult New Zealand White rabbits between the age of 12 - 14 weeks and weighing 2.020 to 2.410 kgs. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm,- by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). Exposure duration was 4 hours. The skin reaction was appraised after 1, 24, 48, 72 hours and 7 days upon removal of the dressings. The score obtained is defined as the "index of primary cutaneous irritation". Due to intensive red staining by the test substance a scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. Index of skin irritation was calculated to be 2.33. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP (Regulation 1272/2008). Hence, the substance FAT 40147/E can be considered as not a skin irritant.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Company code: FAT 40'147/E
Batch No.: EN 94'066.32
Purity: 83.3 %
Appearance: powder
Stability of the test compound: until October 1988
pH-value: 7.9 (1g/l water) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Number and sex of animals used: 3 males
Initial age range: 12 - 14 weeks
Initial body weight range: 2150-2370 G
Individual identification: numbered ear tags. The cages were marked with animal No.and sex, the GU-Project No.and the company code of the test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20±3° C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food NAFAG No.814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst). - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Test Procedure:
0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as the control.
Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. The ocular irritation scores were evaluated.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals
and taking into account the reversibility of the effect.
Symptoms: daily a.m.and p.m. on working days,once daily on weekends and holidays
Body weight: at begin of the acclimatization and at end of test
Mortality: daily a.m.and p.m. on working days,once daily on weekends and holidays - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Due to intensive red staining by the test substance, scoring for corneal opacity was not possible till 7 days (animal no. 1), 48 hours (animal no. 2) and 72 hours (animal no. 3)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- The animals had recovered at the end of the observation period of 10 days.
- Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40147/E can be considered as not an eye irritant.
- Executive summary:
The eye irritation potential of the test substance was evaluated in a study conducted according to OECD Guideline 405. The test was performed on 3 male New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the right eye of the rabbits and the lidsthen held together for about one second in order to prevent loss of the test material. The left eye was not treated and served as an untreated control.The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points.
A slight irritation with conjunctival redness and chemosis was observed. The animals were free of findings by the day 10. The mean score for chemosis was calculated to be 1.8, with two animals having a mean score of 1.7 and one animal having a mean score of 2. Hence, the scores do not meet the classification criteria sert forth by CLP (Regulation 1272/2008). Based on the above findings, the test substance FAT 40147/E can be considered as not an eye irritant.
Reference
Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points (see remarks in the 'Results of in vivo study' for details).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Four in vivo studies to evaluate the skin irritation potential of FAT 40147 are available.
In a key study (1984), the skin irritation potential of the test substance was evaluated according to OECD Guideline 404. The test was performed on 3 female adult New Zealand White rabbits between the age of 12 - 14 weeks and weighing 2.020 to 2.410 kgs. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm,- by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). Exposure duration was 4 hours. The skin reaction was appraised after 1, 24, 48, 72 hours and 7 days upon removal of the dressings. The score obtained is defined as the "index of primary cutaneous irritation". Due to intensive red staining by the test substance a scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The animals had recovered at the end of the observation period of 7 days. Index of skin irritation was calculated to be 2.33. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP (Regulation 1272/2008). Hence, the substance FAT 40147/E can be considered as not a skin irritant.
Similarly, three other studies conducted with FAT 40147/B (1981), FAT 40147/C (1982) and FAT 40147/D (1982) also support the conclusion that the substance is not a skin irritant.
Eye irritation:
Three studies to evaluate the eye irritation potential of FAT 40147 are available.
In a key study, the eye irritation potential of the test substance was evaluated in a study conducted according to OECD Guideline 405. The test was performed on 3 male New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the right eye of the rabbits and the lidsthen held together for about one second in order to prevent loss of the test material. The left eye was not treated and served as an untreated control.The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. Due to intensive red staining, scoring for corneal opacity and conjunctival redness was not possible at certain observation time points. A slight irritation with conjunctival redness and chemosis was observed. The animals were free of findings by the day 10. The mean score for chemosis was calculated to be 1.8, with two animals having a mean score of 1.7 and one animal having a mean score of 2. Hence, the scores do not meet the classification criteria sert forth by CLP (Regulation 1272/2008). Based on the above findings, the test substance FAT 40147/E can be considered as not an eye irritant.
Similarly, two other studies conducted with FAT 40147/B (1981) and FAT 40147/C (1982) also support the conclusion that the substance is not a eye irritant.
Justification for classification or non-classification
Based on the available studies, FAT 40147 does not need to be classified according to CLP (Regulation 1272/2008) criteria.
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