Registration Dossier
Registration Dossier
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EC number: 918-139-9 | CAS number: 1228577-90-9
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:
- other: Study in full compliance with OECD guideline.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,2-Diaminotoluene, propoxylated
- EC Number:
- 918-139-9
- Cas Number:
- 1228577-90-9
- Molecular formula:
- (C3H6O)n (C3H6O)n (C3H6O)n (C3H6O)n C7H10N2 sum of n: >1 - <8.5
- IUPAC Name:
- 1,2-Diaminotoluene, propoxylated
- Details on test material:
- - Name of test material (as cited in study report): Tercarol 5903, NLP # 10 (ortho-Toluene diamine, propoxylated)
- Lot/batch No.: VD 04080734
- Molecular weight: Mn = 340 g/mole
- Physical state: viscous fluid
- Storage condition of test material: room temperature
- Expiration date of the lot/batch: 2009-04-30
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Crl: KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- according to guideline
sex of the test animals: female
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The surrounding untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal. If dermal irritation was observed, additional monitoring on day 7 and 14 after patch removal was done.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water
EXPOSURE PROCEDURE:
Due to a possible irritant potential of the test substance, in the first step only one animal was used and three patches were applied simultaneous. The first patch then was removed after three minutes. If no serious skin reactions were observed, the second patch was removed after one hour. If again no serious skin reactions were observed, the exposure was allowed to extend to four hours. Testing was then completed using two additional animals exposed for four hours.
SCORING SYSTEM: Draize; any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: mean score after 72 h: 0.3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Any other information on results incl. tables
Animal #2 showed 1 hour post application an erythema grade 1, which was fully reversible within 1 day.
Applicant's summary and conclusion
- Executive summary:
An acute dermal irritation/corrosion test (OECD 404) was performed with NLP # 10 (ortho-Toluene diamine, propoxylated). According to classification criteria NLP # 10 is not an irritant to the skin. There were no systemic intolerance reactions.
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