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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Qualifier:
equivalent or similar to guideline
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
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
Value:
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 for cross-reference:
reference to same study
Qualifier:
according to guideline
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
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
Value:
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.