Registration Dossier
Registration Dossier
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EC number: 268-899-4 | CAS number: 68153-95-7 This substance is identified by SDA Substance Name: C12-C18 dialkyl amine and SDA Reporting Number: 16-042-00.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 404
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amines, di-C12-18-alkyl
- EC Number:
- 268-899-4
- EC Name:
- Amines, di-C12-18-alkyl
- Cas Number:
- 68153-95-7
- Molecular formula:
- R2-NH whereas R = mainly C12-18 (even numbered) alkyl molecular weight range is based on R =12 (lower limit value) and R = 18 (higher limit value)
- IUPAC Name:
- N-C12-18-(even numbered)-alkyl-1-C12-18-(even numbered)-amine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 3 minutes
and also 4 hours - Observation period:
- 1 hour - 14 days
- Number of animals:
- 6
- Details on study design:
- patch test
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: after 4 hours exposure to test substance
- Basis:
- other: draize scoring system was used, and reporting was qualitative
- Time point:
- other: 1 hour until 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: clear and severe erythema was seen as well as slight oedema from 1 hour until 14 days after 4 hours exposure.
- Irritation parameter:
- other: after 3 minutes exposure to test substance
- Basis:
- other: draize scoring system was used, and reporting was qualitative
- Time point:
- other: 1 hour until 7 days
- Remarks on result:
- other: after 1 hour slight to clear erythema, after 7 days medium erythma and medium oedema
- Irritant / corrosive response data:
- After 4 hours exposure:
One hour to 14 days severe erythema and slight oedema was noted.Overall the skin was rough dry, swollen whitened and hardened.
After 21 days a scar was noted in one animal.
After 3 minutes exposure:
one hour slight to clear erythem was noted. One day to 7 days slight erythema and slight oedema was noted. After 14 days redness was noted for one animal. Overall the skin was dry, rough and whitened and alopecic.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is corrosive to skin.
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