Registration Dossier
Registration Dossier
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EC number: 249-204-3 | CAS number: 28768-32-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]
- EC Number:
- 249-204-3
- EC Name:
- 4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]
- Cas Number:
- 28768-32-3
- Molecular formula:
- C25H30N2O4
- IUPAC Name:
- 4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
- Reference substance name:
- 4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
- IUPAC Name:
- 4-[[4-[bis(oxiran-2-ylmethyl)amino]phenyl]methyl]-N,N-bis(oxiran-2-ylmethyl)aniline
- Details on test material:
- TK 10884/1, batch-no. EP 760/4.10.84, XB 5023
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 3 male rabbits, weighing 2 - 3 kg (12 - 14 weeks old), were individually housed in metal cages, identified with ear tags, and kept at constant temperature of 20 +/- 3 °C, a relative humidity of 30-70% and at a 12 hour dark/light cycle. m They received diet and water ad libitum Body weight was recorded on days 0, 3, and 7 of the test.
Test system
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 grams per flank of 6 cm2
- Duration of treatment / exposure:
- 4 hours with a semi-occlusive bandage
- Observation period:
- Observation was daily.
Skin reactions and signs of toxicity were recorded at 1 hour, 24, 48, 72 hours , and daily afterwards, - Number of animals:
- three male rabbits
- Details on study design:
- Irritation / corrosion was classified according to EEC guideline 83/467/1983 (Appendix 2).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0.3 - < 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: after 7 days
- Remarks on result:
- other: max. score = 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0.3 - < 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: max. score = 4
- Irritant / corrosive response data:
- The resposnses were mild and the average from 3 animals was lower than minimum for classification and labelling
- Other effects:
- Body weight development was not adversely affected by the treatment
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classificaiton and labelling
- Executive summary:
Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classification and labelling; the product TK 10884/1 is minimally irritating to skin
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