Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
CD(SD)BR/VAF Plus
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Kingston (Stone Ridge, NY)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males 6 to 7 weeks and females 7 to 8 weeks
- Weight at study initiation: Males 162 to 191g and females 161 to 170g
- Fasting period before study: None
- Housing: Singly housed in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Certified rodent diet freely available
- Water (e.g. ad libitum): Water available freely
- Acclimation period: 5 days ahead of study initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 54 to 60%
- Air changes (per hr): Not detailed
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Not detailed (applied to dorsal surface)
- % coverage: Not detailed
- Type of wrap if used: Occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (running water)
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw applied directly


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Statistics:
Not applicable to study design
Preliminary study:
Not conducted
Sex:
male/female
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
Mortality:
No mortality was observed
Clinical signs:
No toxicologically significant clinical signs were observed
Body weight:
No toxicologically significant effects on bodyweight were observed
Gross pathology:
No toxicologically significiant findings were noted at necropsy
Interpretation of results:
GHS criteria not met
Conclusions:
A reliable guideline study indicates that the test material is unlikely to cause dermal toxicity or skin irritation after exposure to the substance, with an LD50 value > 2000 mg/kg bw.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion