Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-06-24 - 1992-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: albino rats (Tif: RAI f (SPF))
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein, Switzerland
- Weight at study initiation: 216 - 290 g
- Housing: Individually in Macrolon cages type 3 with standardized soft wood bedding
- Diet: Standard diet, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Photoperiod: 12 hour/day light cycle

IN-LIFE DATES: From: 1992-07-14/1992-07-23 To: 1992-07-28/1992-08-06

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on dermal exposure:
TEST SITE
- Pretreatment: Area of exposure was shaved 24 hours before application
- Area of exposure: backs of the animals
- % coverage: 10
- Type of wrap: On test day 1 the test item was evenly dispersed on the skin and was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned with lukewarm tap water and the skin reaction was appraised.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Because of the high viscosity of the test item mixture, only 1333 mg/kg bw could be applied, respecting the maximal application volume of 4 mL/kg bw.

VEHICLE
- 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Duration of exposure:
24 hours
Doses:
1333 mg/kg bw
No. of animals per sex per dose:
5 rats
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Observations and records:
Mortality: daily
Signs and symptoms: daily
Body Weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Body weight: Mean and SD

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 333 mg/kg bw
Based on:
test mat.
Mortality:
The following death rate was observed: 0 % at 1333 mg/kg bw.
Clinical signs:
The following clinical signs were observed: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.
Body weight:
The body weight gain of the animals was not affected throughout the study.
Gross pathology:
At necropsy, a spotted thymus was found in two males. No deviations from normal morphology were found in the remaining animals.

Any other information on results incl. tables

Based on the observations, the dermal LD50 value was to be greater than 1333 mg/kg bw.

Because of the high viscosity of the test item mixture, only 1333 mg/kg bw could be applied, respecting the maximal application volume of 4 mL/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an acute dermal toxicity study groups of male and female rats (5/sex) were dermally exposed to the test item (as described in section 1.2) in a standard vehicle for 24 hours to at least 10% of body surface area at a limit dose of 1333 mg/kg bw. Animals then were observed for 14 days. Clinical signs consisted of transient piloerection and hunched posture regarded as common symptoms in acute testing. No mortality occurred in this study. At necropsy, no observable abnormalities were noticed in eight animals and a spotted thymus was found in two males. Based on these observations, the dermal LD50 value of the test item was greater than 1333 mg/kg bw.
Dermal LD50: > 1333 mg/kg bw (per sex and combined)

This study is classified as acceptable. It satisfies the guideline requirement for an acute dermal toxicity study according to OECD 402.