Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CFYstrain
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: in the weight range 252 to 281 g.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST MATERIAL
The substance was prepared as a 75 % aqueous suspension and administered at a dogase volume of 6.7 ml/kg bw by spreading evenly over the prepared skin.

TEST SITE
- Area of exposure: on the day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers. No shaving or chemical depilation was used.
- % coverage: an area equivalent to 10 % of the total body surface.
- Type of wrap if used: the treated area was covered with aluminium foil, which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated area of skin decontaminated by washing with warm (40-50 °C) dilute soap solution, rinsing in clean warm water and finally blotting dry with absorbent paper.
- Time after start of exposure: 24 hours.
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 rats
Control animals:
yes
Remarks:
using water alone
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: treated skin were examined daily for signs of local irritation.
- Necropsy of survivors performed: all rats were sacrificed and examined macroscopically.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no mortalities.
Clinical signs:
Slight lethargy only was observed in all animals in the 24 hours following treatment. No signs of irritation to the skin were seen during the two week observation period.
Recovery of all animals, as judged by external appearance ond behaviour, was apparently complete within 4 days of treatment.
Body weight:
Normal bodyweight gains of the treated animals compared with the controls.
Gross pathology:
Autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 male > 5000 mg/kg bw
Executive summary:

Ten male rats were used to evaluate the acute dermal toxicity potential of the test item. The substance was prepared as a 75 % aqueous suspension and administered at a dogase volume of 6.7 ml/kg bw (5 g/kg bw) by spreading evenly over the prepared skin. The treated area was covered with aluminium foil, which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk. After 24 hours of exposure, the treated area of skin was decontaminated by washing with warm (40-50 °C) diluted soap solution. During the observation period of 14 days, a record was kept of all signs of toxicity. All rats were sacrificed terminally and examined macroscopically. No death occurred.

Slight lethargy only was observed in all animals in the 24 hours following treatment. No signs of irritation to the skin were seen during the 2-week observation period.

Recovery of all animals, as judged by external appearance and behaviour, was apparently complete within 4 days of treatment. Autopsy findings were normal.

Conclusion

LD50 male > 5000 mg/kg bw