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:
comparable to guideline study with acceptable restrictions

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 material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 268 to 290 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region with electric clippers
- % coverage: 10 % of the total body suriace.
- Type of wrap if used: The treated area was then promptly covered with aluminium foil, which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, 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

TEST MATERIAL
- Amount applied: the test item was prepeared as a 75 % aqueous suspension and administered at a dosage volume of 6.7 ml/kg bodyweight by spreading evenly over the prepared skin.
Duration of exposure:
24 hours
Doses:
5000 mg/kg b.w
No. of animals per sex per dose:
10 males per dose
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days (during which a record was kept of all signs of toxicity.
- Necropsy of survivors performed: yes
The treated area of the rats skin was assessed daily for signs of dermal irritation according to the following arbitrary scoring system:
-Erythema and Eschar Formation
No erythema 0
Slight erythema 1
Well defined erythema 2
Moderate erythema 3
Severe erythema (beef redness) to eschar formation (injuries in depth) 4
-Oedema Formation
No oedema 0
Slight oedema 1
Well defined oedema (area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities
Clinical signs:
Shortly after dosing, slight lethargy was observed which persisted until the fourth day after treatment. Slight erythema was observed at the treatment site in one rat on the second day.
Body weight:
Bodyweight increases were normal 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 n. 1272/2008)
Conclusions:
The LD50 in male rats observed over period of 14 days was found to be greated than 5000 mg/kg bw .
Executive summary:

The test substance was administered to 10 male rats by skin route at a dosage level of 5000 mg/kg bodyweight. Animals similary treated using water alone served as control. The substance was prepared as a aqueous suspension and administered by spreading evenly over the prepared skin. There were no mortalities.

The LD50 in rats observed over period of 14 days was found to be greater than 5000 mg/kg bw.