Registration Dossier
Registration Dossier
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EC number: 952-000-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay - Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519; 69120 Heidelberg
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (male animals approx. 9 weeks, female animals approx. 13 weeks)
- Weight at study initiation: females: 210-233 g (mean: 222.8 g, SD: 8.7 g); males: 253-276 g (mean: 263.8 g, SD: 9.76 g)
- Housing: Single housing, in Makrolon cages, type III with wooden gnawing blocks
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days before administration
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3
- Humidity (%): 30-70
- Air changes (per hr): approx. 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: About 40 cm²
- % coverage: At least 10% of the total body surface
REMOVAL OF TEST SUBSTANCE
- Washing: With warm water
- Time after start of exposure: After 24 hours
TEST MATERIAL
- Amount applied: 2.27 mL/kg bw
- Concentration: Undiluted
- Constant volume or concentration used: Yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (both males and females)
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weights: Shortly before application (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Several times on the day of application and at least once during each workday thereafter.
Mortality: At least once each workday
Scoring of skin findings: 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), then several times until the last day of observation.
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. - Statistics:
- not performed
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- Very slight erythema (grade 1) in 5/5 females on day 1 and in 2/5 until day 3
- Mortality:
- No mortality occurred.
- Clinical signs:
- No systemic clinical signs were observed during clinical examination.
- Body weight:
- All animals gained weight in a normal range throughout the study period.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in any animal examined on the last day of observation (5 males and 5 females).
- Other findings:
- Local effects
- Males: No local effects were observed.
- Females: Very slight erythema (grade 1) was seen in all female animals on study day 1 and persisted in in two of these animals until study day 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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