Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 May - 17 June 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No information on purity was given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
No information on purity was given.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 10 - 12 weeks
- Weight at study initiation: 262 - 285 g (males), 237 - 264 g (females)
- Housing: individually during the 24 h exposure period and subsequently up to 5 animals of the same sex per cage in polypropylene cages on sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45 - 66
- 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: skin of the dorsal, lateral and ventral regions (6 cm x 12 cm)
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze patch (7 cm x 4 cm) which was held in place with a strip of elastic adhesive bandage (7.5 cm wide and 25-30 cm long) wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: 0.06, 0.46, 2.29 and 5.71 mL/kg bw (range-finding study); 5.71 mL/kg bw (main study)
- Constant concentration used: yes
Duration of exposure:
24 h
Doses:
Range-finding study: 50, 400, 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw
No. of animals per sex per dose:
Range-finding study: 2
Main study: 5
Control animals:
not required
Details on study design:
Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 30 min and 1 and 4 h after administration and subsequently once daily for 7 days.

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 3, 4 and 5 h after administration and subsequently at least once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
No deaths or clinical signs of toxicity were noted up to the highest concentration tested throughout the 7-day observation period. The dose level selected for the main study was therefore 5000 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No signs of systemic toxicity were noted until the end of the observation period.
Body weight:
Body weight development was unremarkable. All animals gained weight during the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.
Executive summary:

An acute dermal toxicity study was performed with male and female rats according to OECD 402 under GLP conditions. After a range-finding study with the dose levels 50, 400, 2000 and 5000 mg/kg bw, a main study with 5000 mg/kg bw was performed. No mortality occurred during the study period of the range-finding study and the main study.

In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.