Registration Dossier

Administrative data

Description of key information

LD50 oral (rat): > 2000 mg/kg bw [Draft report, Treher 1994]
LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Stark 2001]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from June to August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Reference:
Composition 1
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
- all three dose levels were testd although no mortalities occured after 2000 mg/kg in both sexes
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
other: HAN:WIST (SPF)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 0.9 % NaCl + 0.085 % Myrj 53 in bidist. water
Doses:
25, 200 and 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

No animal died in the course of the study. After single oral application 25, 200 or 2000 mg/kg no clinical findings were observed in male and female animals. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at 25, 200 and 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from September to October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Reason / purpose:
reference to same study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- 3 instead of 5 animals/sex used
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
other: Shoe:Wist
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
other: 0.9 % sodium chloride solution
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

At 2000 mg/kg no compound-related clinical findings were observed. Two male and one female rat showed a body weight loss in week 1. In addition, one of the two male rats showed a reduced body weight gain throughout the study period, when compared to the 90% range of historical reference data used in our laboratory. Autopsy revealed no compound-related findings. No animal died in the course of the study.

Executive summary:

The acute dermal toxicity of the test substance was low with a LD50 value exceeding 2000 mg/kg bw in rats according to OECD TG 402. At the limit-dose 2000 mg/kg no animal died, no clinical findings, slight efffects on body weight gain and no gross pathological findings were observed during the 14-day post observation period.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

A single oral administration of the test substance by gavage to male and female rats at 25, 200 and 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings.According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.

The acute dermal toxicity of the test substance was low with a LD50 value exceeding 2000 mg/kg bw in rats according to OECD TG 402. At the limit-dose 2000 mg/kg no animal died, no clinical findings, slight efffects on body weight gain and no gross pathological findings were observed during the 14-day post observation period.


Justification for selection of acute toxicity – oral endpoint
Only one reliability 1 study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required.