Registration Dossier
Registration Dossier
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EC number: 940-877-5 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Jul - 25 Jul 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(3,4-dimethyl-1H-pyrazol-1-yl)butanedioic acid; 2-(4,5-dimethyl-1H-pyrazol-1-yl)butanedioic acid
- EC Number:
- 940-877-5
- Cas Number:
- 2241455-89-8
- Molecular formula:
- C9H12N2O4
- IUPAC Name:
- 2-(3,4-dimethyl-1H-pyrazol-1-yl)butanedioic acid; 2-(4,5-dimethyl-1H-pyrazol-1-yl)butanedioic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8-9 weeks (males), 11-12 weeks (females)
- Weight at study initiation: 239-253 g (males), 203-220 g (females)
- Fasting period before study: no data
- Housing: single housing in IVC cages, type III H
- Diet: Altromin 1324 maintenance diet for rats and mice (Lot No. 0906), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: at least 10 cm²
- % coverage: approximately 10%
- Type of wrap if used: gauze-dresssing and non-irritating tape fixed with an additional semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: removed with cottonseed oil
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the application) and on days 8 and 15. Clinical examination was made several times on the day of dosing and once daily until the end of the observation period.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- No mortailty occurred.
- Clinical signs:
- other: No signs of systemic toxicity were observed throughout the whole study period. No signs of dermal irritation were observed in any animal.
- Body weight:
- other body weight observations
- Remarks:
- The body weight development of all male and female animals was within expected range. A weight loss was recorded for 1 out of 5 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The male animals showed weight gain during the first and the second week of the observation.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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