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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: The test procedure cannot be subsumed under a testing guideline, nevertheless are scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Acute percutaneous toxicity test.
The acute dermal toxicity of the test item was investigated in male rats, in a 40 % of aqueous gum tragacanth. 12.5 ml of the substance was spreaded dermally and covered with an aluminum foil. After the exposure time of 24 hours, mortalities, signs of toxicity and dermal toxicity were observed.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 229 - 249 g.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: aqueous gum tragacanth (0.5 %)
Details on dermal exposure:
TEST CONCENTRATION
- Dose concentration: 12.5 ml/kg at 40 % of substance.

TEST SITE
- Area of exposure: dorso-lumbar region, 10 % of the total body surface.
- Hair removing method: electric clippers. No shaving or chemical depilation.
- Day of the preparation: one day prior to treatment.
- Type of wrap if used: with "Sleek" waterproof plaster, firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing with warm diluted soap solution (40-50 °C), rinsing in clean warm water and blotting dry with absorbent paper.
Duration of exposure:
24 hours.
Doses:
0 and 5000 mg/l.
No. of animals per sex per dose:
5 males per dose.
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days.
- Observations: daily, for signs of of dermal irritation, according to the scoring system. All animals were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities were found.
Clinical signs:
No signs of toxicity were observed.
Body weight:
Slightly depressed bodyweight gains were observed during the first week of treatment, but returned to normaI during the second week , compared with controls.
Gross pathology:
Normal.
Other findings:
No dermal reactions were observed.

Any other information on results incl. tables

Results

Sex Dosage level Body weight (g) at Mortality
Male (g/kg) Dosing 1 week 2 weeks
0 249 327 382 0/5
5 243 270 318 0/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 (percutaneous) > 5000 mg/l, non toxic.
Executive summary:

Method

The acute dermal toxicity of the test item was investigated in male rats, in a 40 % of aqueous gum tragacanth. 12.5 ml of the substance was spreaded dermally and covered with an aluminum foil. After the exposure time of 24 hours, mortalities, signs of toxicity and dermal toxicity were observed.

Results

The percutaneous LD50 was > 5000 mg/l, therefore the test item could be considered non toxic.