Registration Dossier
Registration Dossier
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EC number: 202-374-2 | CAS number: 94-91-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- α,α'-propylenedinitrilodi-o-cresol
- EC Number:
- 202-374-2
- EC Name:
- α,α'-propylenedinitrilodi-o-cresol
- Cas Number:
- 94-91-7
- Molecular formula:
- C17H18N2O2
- IUPAC Name:
- α,α'-propylenedinitrilodi-o-cresol
- Details on test material:
- - Name of test material (as cited in study report): alpha,alpha'-Propylenedinitrilodi-o-cresol
- Physical state: Highly viscous to solid, melt
- Analytical purity: > 99.0 corr. area-% determined by Capillary GC
- Lot/batch No.: 11000129U0
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
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 Wiga GmbH
- Age at study initiation: approx. 8 weeks (males); approx. 12 weeks (females)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight); mean weight males: 235.6 g; mean weight females: 208 g
- Fasting period before study: N/A
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: at least 10% of the body surface
- Type of wrap if used: semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: after 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 50 g/100 mL
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of
observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. A check for any dead or moribund animals was made at least once each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination. Very slight erythema (grade 1) was noted in three male animals at day 1 and persisted in two of these animals until study day 3 or increased to well-defined erythema (grade 2) in the t
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the acute dermal median lethal dose (LD50) of > 2000 mg/kg bw, the substance does not meet the GHS criteria for classification for Acute Demal toxicity
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