Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 December 1995 to 21 December 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): M-377
- Physical state: solid
- Appearance: garnet powder
- Storage condition of test material: room temperature and protected from light

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Sprague-Dawley ICO: OFA-SD (IOPS Caw)
- Age at study initiation: approximately 8 weeks
- Weight at study initiation (mean ± standard deviation): 287 ± 4 g (males); 230 ± 5 g (females)
- Housing: Animals of the same sex caged in groups of 4 - 7 in polycarbonate cages (48 cm x 27 cm x 20 cm) during acclimatisation; animals were caged individually (35.5 cm x 23.5 cm x 19.3 cm) during treatment period.
- Diet: pelleted diet, ad libitum
- Water: Filtered drinking water (0.22 µm), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 7 December 1995 to 21 December 1995

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
On the day before treatment, the dorsal area (6 cm x 8 cm) of each animal was clipped free of fur. A single dose of 2000 mg/kg of the test material, moistened with 2 mL water, was applied to the test site on a hydrophilic gauze pad. The gauze covered an area representing approximately 10 % of the body surface area of the animals. The gauze pad was held in place by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.

REMOVAL OF TEST SUBSTANCE
Any residual test material was removed with a moistened (distilled water) gauze pad.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
The volume applied to each animal was adjusted according to body weight determined on the day of treatment.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed frequently during the hours following administration of the test material and at least once daily thereafter.
- Frequency of weighing: animals were weighed individually just before administration of the test material on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen, and any other organs with obvious abnormalities) was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
No clinical signs and no cutaneous reactions were observed during the study.
Very slight to moderate red colouration of the test site was noted in all animals up to day 5.
Body weight:
The body weight gain of the animals were not influenced by treatment.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was subsequently determined to be in excess of 2000 mg/kg bw. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402 and EU Method B.3. Five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. Very slight to moderate red colouration of the test site was noted in all animals up to day 5. The body weight gain of the animals was not influenced by treatment. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was subsequently estimated to be in excess of 2000 mg/kg to both male and female rats.