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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (TS purity not specified; size of application area not reported; 4 animals used (without justification); abraded skin was treated in 2 animals)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
4 animals used (without justification); abraded skin was treated in 2 animals; size of application area not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: red powder
- 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: local supplier
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in elevated wire mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): water from bottles ad lib.
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back, intact or abraded skin (each 2 animals; abraded with a 21 gauge bent tip needle. The abrasions, made every 2 to 3 cm longitudinally, scratched the stratum corneum, but did not disturb the derma or produce bleeding)
- % coverage: not reported (regarding the body weight of ca. 2500 mg and the formula BSA = 9.5 * (body weight in g)exp(2/3), the test site should be > 180 cm2 for guideline conformity)
- Type of wrap if used: impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water

TEST MATERIAL
- Concentration (if solution): 50% w/v suspension in distilled water
- Constant volume or concentration used: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: once daily; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local effects according to OECD Draize scheme after 25 hours, 7 and 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Abrasion (2/4 animals) had no effect on local or systemic effects
Mortality:
no mortality
Clinical signs:
in 1 animal (intact skin): Diarrhea, days 3 & 4 and 7 to 10; Abdomen bloated, days 4 to 7; Anorexia, days 5 and 6; Adipsia, days 5 and 6; no fecal matter in pan day 5.
Body weight:
Body weight gain was inconsistent in the four animals (slight loss of weight in 2 animals in the first week and in a third animal in the second week; constant weight gain in the 4th animal). Since no data of control animals were available, a treatment effect cannot be excluded but is considered as unlikely.
Gross pathology:
One animal had yellow exudate from nose/mouth and another had bloated intestines. No abnormal findings in the other two animals (with abraded skin).
Other findings:
Neither erythema nor edema were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information