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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:
8 December 1993 to 19 May 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: solid
- Storage condition of test material: in the dark at ambient room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: four months old
- Weight at study initiation: 2.68-2.90 kg (male); 2.84-3.09 (female)
- Housing: individually in suspended stainless steel cages
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 15-23 ºC
- Humidity: 40-70 %
- Air changes: at least 10
- Photoperiod: 12 hours light/12 hours dark

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 12 cm x 14 cm
- % coverage: approximately 10 %
- Type of wrap if used: unmedicated gauze patch; occluded with aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with wet tissues
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: three separate observations were made during the first hour after administration and two further recordings were made during day 1. From day 2 onwards, the animals were inspected at least twice daily and recordings of systemic signs made once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: body weights were recorded on the day before dosing and days 1, 8 and 15.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two female rabbits were found dead on day 5
Clinical signs:
Ante mortem signs comprised under-activity, pallor, cold to touch, pigmented straining of the snout and closed eyes. One surviving female rabbit showed pallor on day 4. The other surviving animals showed no systemic or local sign of reaction to treatment.
Body weight:
The surviving animals achieved expected body weight gains.
Gross pathology:
Necropsy of the deceased animals revealed blood staining around the mouth and nares of both animals, dark tracheal contents and dark areas on the left lung lobe of one animal and dark fluid in the thorax and abdomen of the other animal. The latter animal also had a thickened dermal application site with dark encrustations.

Necropsy of the surviving animals revealed no significant internal macroscopic lesion, although one animal had multiple dark areas in the musculature below the application site.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material was >2000 mg/kg.
Executive summary:

In a GLP compliant acute dermal toxicity study conducted in line with standardised guidelines OECD 402, EU Method B.3 and EPA FIFRA Guideline 81-2, the acute dermal toxicity of the test material was determined.

Under the conditions of the test, the LD50 of the test material was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for this endpoint.