Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- See attached document with the justification for the category/read-across approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 24 hour occlusive exposure with observations at 24 and 48 hours after start of exposure.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 907-870-9
- EC Number:
- 907-870-9
- Molecular formula:
- Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
- IUPAC Name:
- 907-870-9
- Test material form:
- liquid
- Details on test material:
- Mix of Diisobutyl esters:
34% Diisobutyl succinate
55% Diisobutyl glutarate
11% diisobutyl adipate
Overall purity 99.94%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of the pure substance
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours
- Number of animals:
- 6 (male)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Erythema:
At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction
At 48 hours 4 animals had no reaction and 2 animals had a slight reaction
Edema
At 24 hours 1 animal had a slight reaction and 5 had no reaction
At 48 hours no animals had reactions.
This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
Any other information on results incl. tables
Erythema:
At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction
At 48 hours 4 animals had no reaction and 2 animals had a slight reaction
Edema
At 24 hours 1 animal had a slight reaction and 5 had no reaction
At 48 hours no animals had reactions.
This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This substance produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
- Executive summary:
Doses of 0.1ml of test compound applied to intact skin of rabbits under 1 1/2 inch by 1 1/2 inch, 12 -ply gauze squares. Rubber sheeting was then loosely wrapped around the trunk and secured with tape. After 24 hours the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours. Erythema and edema were scored qualitatively as negative, slight, mild, moderate or severe.
This substance produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
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