Registration Dossier
Registration Dossier
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EC number: 247-426-5 | CAS number: 26040-51-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the test material to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessed according to Draize 1, 24, 48 and 72 hours after removal of the dressings.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) tetrabromophthalate
- EC Number:
- 247-426-5
- EC Name:
- Bis(2-ethylhexyl) tetrabromophthalate
- Cas Number:
- 26040-51-7
- Molecular formula:
- C24H34Br4O4
- IUPAC Name:
- 1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate
- Test material form:
- liquid
- Details on test material:
- RC 9927 (batch 6159-199-3), also identified as FR-45B, a slightly turbid, viscous pale yellow liquid received from Pennwalt Corporation on 1st September 1986.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male and 3 female animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, score = 0 at any time point
Any other information on results incl. tables
Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent.
all dermal irritation responses had resolved by the 48 -hour examination.
The control sites did not show any response to the control procedure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The potential of RC9927 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 ml of the testmaterial to the closely-clipped dorsa of 3 male and 3 female New Zealand White rabbits for four hours. Dermal reactions were assessedaccording to Draize 1, 24, 48 and 72 hours after removal of the dressings.
Very slight erythema was observed at 3 test sites one hour after removal of the dressings, and in one animal only at the 24 -hour examination. No other changes were apparent. All dermal irritation responses had resolved by the 48 -hour examination.
The control sites did not show any response to the control procedure.
Under the conditions of this test, RC9927 was not irritating to the skin.
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