Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-10-26 to 1990-01-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted Mar 1984
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 weeks (males), 12 weeks (females)
- Weight at study initiation: 241-269 g (males), 201-219 g (females)
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batches 55/89 and 60/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
bi-distilled
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- % coverage: 10
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin was washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration (if solution): 500 mg/mL
- Constant volume or concentration used: yes
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:
Mortality/Viability: four times on Day 1 and daily thereafter until Day 15
Body Weights: on Day 1 (pre-administration), 8 and 15
Clinical Signs: four times during Day 1 and daily thereafter until Day 15
- 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.
Mortality:
No mortality occurred up to the end of the 14-day observation period.
Clinical signs:
No clinical signswere observed up to the end of the 14-day observation period.
Body weight:
The body weight gain of the animals was not affected throughout the study by test article treatment.
Gross pathology:
Macroscopical findings were limited to one male animal showing dark red discolouration of the lungs, and one female showing pale discolouration of the lungs. No abnormalities were observed in the remaining male and female animals.
Other findings:
The following local signs were observed on the back of the animals:
2000 mg/kg: males/females - scales, yellow skin.
The rats had recovered from local signs after 8 (males) and 11 (females) observation days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 in male and female Wistar rats was determined to be greater than 2000 mg/kg bw. There were no treatment-related deaths, no clinical signs of systemic toxicity and no abnormal changes in body weight. Local signs (scales, yellow skin) were observed in all animals and were fully reversible by study Day 8 and 11 in males and females, respectively. Macroscopical findings were limited to one male (dark red discolouration of the lungs) and one female (pale discolouration of the lungs).
Based on the study results, the substance does not fulfil the criteria for classification in accordance with Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not acutely toxic by the dermal route.