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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butindiol
- Analytical purity: 98.9 % (2.TV), 98.9 % (1.TV)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: male: 7 - 8 weeks, female: 8 -9 weeks
- Weight at study initiation: male: 209 g +/- 12 g female: 199 g +/- 10 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours, warm water
Duration of exposure:
24 hours
Doses:
male: 50, 100, 200, 400, 2000 mg/kg b.w.
female: 400, 1250, 1600, 2000 mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
659 mg/kg bw
Based on:
test mat.
95% CL:
324 - 1 440
Sex:
male
Dose descriptor:
other: NOAEL
Effect level:
50 mg/kg bw
Based on:
test mat.
Clinical signs:
reduced spontaneous activity, crouch, retacted flank, constricted palpebral fissure, piloerection, decreased respiratory frequency,
high-stepping gait, unsteady gait
Body weight:
The body wight gain of the animals was reduced in the first week.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg b.w.)  Male animals  Female animals
 50  0/5  -
 100  1/5  -
 200  2/5  -
 400  2/5  0/5
 1250  3/5
 1600  -  3/5
 2000  4/5  5/5

LD50 male animals: 424 (178 - 1880) mg/kg b.w.;          
LD50 female animals: 983 (307 - 2440) mg/kg b.w.;
LD50 male + female animals: 659 (324 - 1440) mg/kg b.w.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Category 3 Criteria used for interpretation of results: EU