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EC number: 271-968-1 | CAS number: 68647-71-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 January 1992 to 22 February 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- Study conducted before the requirement of LLNA study was implemented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An OECD 406 test was already conducted so it was considered unethical to run an LLNA test for animal welfare reasons.
Test material
- Reference substance name:
- Tall oil
- EC Number:
- 232-304-6
- EC Name:
- Tall oil
- Cas Number:
- 8002-26-4
- Molecular formula:
- Not applicable as it is a UVCB
- IUPAC Name:
- Distilled Tall oil
- Test material form:
- other: liquid (unspecified)
- Details on test material:
- - Appearance: yellowish-brown liquid
- Storage conditions: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 6 to 7 weeks on arrival.
- Weight at study initiation: 301 to 370 g on arrival.
- Housing: The guinea-pigs were housed in groups of ten in suspended metal cages with wire mesh floors.
- Diet (e.g. ad libitum): A vitamin C enriched guinea-pig diet was provided ad libitum. Hay was given weekly.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 12 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 °C.
- Humidity (%): 30 to 70 % relative humidity.
- Air changes (per hr): Air exchange was maintained at approximately 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 to 1900 hours) in each 24 hour period.
IN-LIFE DATES: From: 28 January 1992 To: 22 February 1992
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: Intradermal and topical
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction intradermal injection - 7.5 %
Induction topical application - as supplied
Topical challenge - as supplied and 50 % v/v
Challengeopen allclose all
- Route:
- other: topical
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction intradermal injection - 7.5 %
Induction topical application - as supplied
Topical challenge - as supplied and 50 % v/v
- No. of animals per dose:
- 20 animals were used for the test group.
- Details on study design:
- RANGE FINDING TESTS: Yes. Animals were exposed to the test material in the intradermal induction at concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0 % v/v. For the topical induction, the animals were exposed to the test material at concentrations of 50, 60 and 75 % v/v and as supplied.
MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INJECTIONS
A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 2 x 4 cm area within the clipped area as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation (Ph.Eur.).
2. Test material 7.5 % v/v in Alembicol D.
3. Test material 7.5 % v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
TOPICAL APPLICATION
The preliminary investigation indicated that the maximum practical concentration of the test material for topical application (as supplied) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.2 mL per site of 10 % w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later, a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 mL of the test material, as supplied. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
In the induction phase, the control animals were treated similarly with the exception that the test material was omitted.
B. CHALLENGE EXPOSURE
The control and test animals were challenged topically two weeks after the topical induction application using the test material as supplied and 50 % v/v in Alembicol D.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 20 x 20 mm patch of Whatman No. 3 paper was saturated with approximately 0.2 mL of the test material as supplied and applied to an anterior site on the flank. The test material 50 % v/v in Alembicol D was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek".
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches.
OBSERVATIONS
- Clinical signs: All animals were observed daily for signs of ill health or toxicity.
- Bodyweight: The bodyweight of each guinea-pig on the main study was recorded on Day 1 (day of intradermal injections) and on the last day of observation of dermal responses in the challenge.
- Dermal responses: The dermal reactions resulting from intradermal injection and topical application on the preliminary study, and topical application at the challenge were assessed using the following numerical system.
Erythema and eschar formation:
No erythema 0
Slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
No oedema 0
Slight oedema 1
Well-defined oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Any other lesion not covered by this scoring system was described.
INTERPRETATION OF RESULTS
Dermal reactions in the test animals elicited by the challenge application were compared with the findings simultaneously obtained in the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in control animals, the result for that test animal was classified as inconclusive.
A test animal was considered to show no evidence of delayed contact hypersensitivity if the dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group. - Positive control substance(s):
- yes
- Remarks:
- Formalin
Results and discussion
- Positive control results:
- The sensitivity of the guinea-pig strain used at the testing facility was checked periodically with formalin. Formalin was shown to cause sensitisation and therefore demonstrate the suitability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Test material as supplied and 50 % v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Test material as supplied and 50 % v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Test material as supplied and 50 % v/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Formalin
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Formalin
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Formalin
- No. with + reactions:
- 20
- Total no. in group:
- 20
Any other information on results incl. tables
Clinical Signs
No signs of ill health or toxicity were recorded.
Bodyweight
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
Induction
- Intradermal injections: Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Irritation was seen in test animals at sites receiving the test material 7.5 % v/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.
- Topical application: Slight erythema was observed in test animals following topical application with the test material as supplied. Very slight erythema was seen in the control guinea-pigs.
Challenge
The dermal responses seen in the test animals were similar to those of the controls.
Table 1 Dermal Reactions Observed After Induction
Site |
Intradermal injection |
Topical Application |
||
Test Animals |
Control Animals |
Test Animals |
Control Animals |
|
1 |
Necrosis |
Necrosis |
Slight erythema |
Very Slight erythema |
2 |
Irritation |
Slight irritation |
||
3 |
Necrosis |
Necrosis |
Table 2 Dermal Reactions Observed After the Challenge Application in Control Animals
Guinea-Pig Number |
|
Score |
Guinea-Pig Number |
|
Score |
||||||||||
24 Hours |
48 Hours |
72 Hours |
24 Hours |
48 Hours |
72 Hours |
||||||||||
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
||||
200 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
210 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
201 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
211 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
202 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
212 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
203 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
213 |
E O |
L1 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
204 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
214 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
205 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
215 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
206 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
216 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
207 |
E O |
L1* 0 |
0 0 |
L1* 0 |
0 0 |
0* 0 |
0 0 |
217 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
208 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
218 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
209 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
219 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
E = Erythema
O = Oedema
L = Localised dermal reaction restricted to a small area of the challenge site.
*= Dryness and sloughing of the epidermis.
A = Anterior site, exposed to the test material as supplied.
P = Posterior site, exposed to the test material 50 % v/v in Alembicol D
Table 3 Dermal Reactions Observed After the Challenge Application in Test Animals
Guinea-Pig Number |
|
Score |
Result |
Guinea-Pig Number |
|
Score |
Result |
||||||||||
24 Hours |
48 Hours |
72 Hours |
24 Hours |
48 Hours |
72 Hours |
||||||||||||
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
A |
P |
||||||
220 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
- |
230 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
221 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
231 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
222 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
232 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
223 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
233 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
224 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
234 |
E O |
0* 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
- |
225 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
235 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
226 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
- |
236 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
227 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
237 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
228 |
E O |
0 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
- |
238 |
E O |
L1 0 |
0 0 |
0* 0 |
0 0 |
0* 0 |
0 0 |
- |
229 |
E O |
L1* 0 |
0 0 |
0* 0 |
0* 0 |
0* 0 |
0 0 |
- |
239 |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
E = Erythema
O = Oedema
L = Localised dermal reaction restricted to a small area of the challenge site.
*= Dryness and sloughing of the epidermis.
A = Anterior site, exposed to the test material as supplied.
P = Posterior site, exposed to the test material 50 % v/v in Alembicol D
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the conditions of this study, the test material did not produce evidence of skin sensitisation and therefore requires no classification in accordance with EU criteria.
- Executive summary:
The potential of the test substance to cause skin sensitisation (delayed contact hypersensitivity) was investigated in a guinea-pig maximisation test conducted in accordance with the standardised guideline OECD 406 under GLP conditions. Twenty albino Dunkin-Hartley guinea-pigs were exposed to the test material. The concentrations used in the induction phase of the study were 7.5 % v/v in Alembicol D for the intradermal application and undiluted test material for the topical application. Formalin was used as the positive control substance. In the challenge application, the animals were exposed to the test material as supplied and 50 % v/v in Alembicol D. No signs of ill health or toxicity were observed throughout the study. The test material elicited dermal reactions similar to those seen in the control animals. Under the conditions of this study, the test material did not produce evidence of skin sensitisation (Parcell, 1992).
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