Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 April to 10 May 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to EC and OECD test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: Yellow powder
- Physical state: solid
- Analytical purity: 100%
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: not determined
- Storage condition of test material: Ambient temperature, in the dark.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England
- Age at study initiation: seven to ten weeks
- Weight at study initiation: 203 to 250 grams
- Fasting period before study: no
- Housing:housed individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet (Labsure LAD1) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 58%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50x50 mm
- % coverage: 100%
- Type of wrap if used: covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressings were carefully removed and the treated area of skin decontaminated by washing in warm (30°-40°C) water and blotting dry with
absorbent paper.

- Time after start of exposure: after 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2.25 ml/kg.
- Concentration (if solution): Unifoam AZ SO-NL was prepared as a 88.9% w/v paste in distilled water and administered at a volume of 2.25 ml/kg.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:
24 hours
Doses:
2 g/kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on weekdays and 11.30 hours on Saturday and Sunday. Clinical signs were recorded at each observation. The treated areas of skin were examined daily for signs of dermal irritation and assessed according to an arbitrary scoring system.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals on the study were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths following a single dermal dose of Unifoam AZ SO-NL at 2.0 g/kg bodyweight.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
Slightly low bodyweight gains were recorded on Day 8 for a single male and on Day 15 for two male and two female rats.
Other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
Sites of application of the test substance showed no irritation reactions or other dermal changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats of Unifoam AZ SO-NL was found to be: greater than 2.0 g/kg bodyweight.
Executive summary:

An acute dermal toxicity study was conducted to assess the toxicity of the test substance AZ SO-NL by dermal exposure (HLS 1988, 88726D/OCI 65/AC). The study was conducted in accordance with EC and OECD test guidelines, and in compliance with GLP.

Ten rats (five males and five females) were exposed to the test substance by dermal exposure at 2.0 g/kg bodyweight for a period of 24 hours. At the end of the exposure period, the test substance was washed off, and the test animals were observed for mortality, clinical signs and signs of dermal irritation for a period of 14 days after exposure. At the end of the observation period, all test animals were sacrificed and post mortem examinations were performed.

No deaths occurred in the test animals during the exposure or observation periods. No clinical signs or dermal responses were observed, and terminal autopsy results were normal. Slightly low bodyweight gains were seen in two male and two female rats at the end of the observation period.

The acute lethal dermal dose to rats of Unifoam AZ SO-NL was found to be greater than 2.0 g/kg bodyweight.