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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-05-18 until 1995-05-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study similar to current OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.2 - 2.9 kg
- Housing: metal cages with wire mesh floors
- Diet: a standard laboratory rodent diet (SDS Rabbit diet SQC), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70 %
- Air changes: 10 - 15 air changes per hour
- Photoperiod: 12 hours of artificial light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 1 % w/v aqueous methylcellulose
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: The treated area (approximately 50 mm x 50 mm) was promptly covered with two layers of gauze which were held in place with a non-irritative elastic adhesive bandage encircled firmly around the trunk. This bandage was secured with waterproof strapping BP tape to provide a semi-occlusive wrapping which inhibited evaporation and inhalation of the test material or wetting agent and also prevented the animal from ingesting the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL AND VEHICLE
The test substance was prepared at a maximum practical concentration of 83.33 % w/v in 1 % w/v aqueous methylcellulose and administered at a volume of 6 mL/kg bw.

Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals: 5 males, 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily - for clinical signs. Body weights were recorded on days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
A slight bodyweight loss was recorded for one male on day 8 and for one female on day 15. In addition, one further male showed a slightly low bodyweight gain on day 15. All other rabbits achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
Macroscopic examination on day 15 revealed congestion in the kidney of one female only.
Other findings:
Dermal responses:
A residual (yellow/brown) staining from the test substance was evident at all treatment sites following the removal of the dressings and over the following days. This did not inhibit assessment for dermal responses. Slight to well-defined erythema and oedema were evident in all rabbits during the first week of the study. These reactions were accompanied in three females by desquamation (characterised by dryness and localised spots/scab formation). There were no other dermal responses and reactions gradually subsided in the majority of instances during the latter part of week 1, with recovery complete in all instances by day 13.

Applicant's summary and conclusion