Registration Dossier
Registration Dossier
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EC number: 406-200-8 | CAS number: 117827-06-2 COUPLER II; UC-136
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- EC Number:
- 406-200-8
- EC Name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- Cas Number:
- 117827-06-2
- Molecular formula:
- C24H39Cl2NO2
- IUPAC Name:
- N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
- Details on test material:
- UC-136
White powder
Batch number : unknown
Purity 98.5%
Storage conditions: at room temperature in the dark in a tighly sealed container
Stability of test substance: stable for one year maximal under storage conditions
Stability of test article in vehicle : unknown
Safety precautions: gloves and goggles were used to assure personnel health and safety
The test was performed in a fume cupboard.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Original Source Charles River Wiga, Sulzfeld, West—Germany.
Total number of animals 3 females
Age at start of treatment Approx. 14 weeks
Body weight at start of treatment 2533 — 2936 gram
Identification Ear tag.
Acclimatisation At least five days under test conditions.
HUSBANDRY
Room No.: 9
Conditions
Standard Laboratory Conditions. Air—conditioned with 7.5—15 air changes per hour and hourly monitored environment with temperature 21 ± 3°C and relative ~ humidity 30—88%, 12 hours artificial fluorescent light / 12 hours dark.
Accommodation
Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen / The Netherlands).
Diet
Standard laboratory rabbit diet (LKK—20, pellet diameter 4mm, Hope Farms, Woerden I The Netherlands) approx. 100 gram per day. Certificates of analysis are retained in the RCC NOTOX archives.
Water
Free access to tap—water diluted with decalcified water. Certificates of analysis of tap—water are retained in the RCC NOTOX archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Solid: 0.5 g/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- No skin irritation was observed.
No corrosive effect was evident on the skin. - Other effects:
- In the area of application no staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- UC—136 resulted in a primary irritation index of 0 (non—irritating) when applied to the intact rabbit skin.
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