Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
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 or test system 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:
other: No toxicologically significant clinical signs 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