Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Jan - Feb 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Deviations:
no
Principles of method if other than guideline:
The study was performed in accordance with the Hazleton Manual of Standard Operating Procedures as applied to the client procedure supplied ( Procter and Gamble Standard Procedure No. 10 for Toxicological Evaluation) dated 24th June 1977.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E8296: Armeen CD - Stearic acid
- Physical state / appearance: white solid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buxted Rabbit Co. Ltd, Great Totease Farm, Buxted, Nr. Uckfield, Sussex
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually in grid floor cages
- Diet (ad libitum): Standard Rabbit Diet
- Water (ad libitum): drinking water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ambient with a lower limit of 14
- Photoperiod: natural lighting conditions

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: 25% of the total body surface (on the back)
- Type of wrap if used: gauze pads ( 80 x 120 mm) and secured by adhesive strapping. Each animal was placed into a Newman harness.

REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after administration with a wet disposable paper towel
Duration of exposure:
24 hours
Doses:
2000 mg / kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily for mortality and signs of toxicity for the 14 days following administration
- Frequency of observations to evaluate skin reactions: immediately after removal of the patches and daily for the next two weeks
- Frequency of weighing: once before administration of the test substance and thereafter on day 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One male animal was found dead on day 7 after treatment. Laboured breathing was noted in this animal on the day before death (Day 6). Severely consolidated lungs were noted at necropsy and death was not considered to be related to treatment.
Clinical signs:
Slight diarrhoea was noted in one female animal ( No. 893) on day 3 after treatment. All other animals appeared normal throughout the observation period.
Body weight:
One animal showed a small loss in body weight at the end of the observation period. All other surviving animals showed small to moderate body weight gains.
Gross pathology:
Necropsy of all surviving animals revealed no macroscopic abnormalities. One animal received for necropsy on day 7 showed severe consolidation of the lungs.
Other findings:
Erythema, ranging from slight to moderate in degree, was noted on removal of the adhesive dressing. The erythema was maintained and became severe in degree in one female animal 7 days after treatment. Four animals showed slight and moderate desquamation.
Slight oedema and eschar formation were also noted in some animals during the first week of observation.

Applicant's summary and conclusion