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Diss Factsheets

Administrative data

Description of key information

LD50 oral (rat): > 2000 mg/kg bw [report No. A11270, Wick 2004]
LD50 dermal (rat): > 2000 mg/kg bw [report No. 11076, Döhr 2004]

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:
July to August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Shoe: WIST (SPF)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 9.00 mg NaCl + 0.85 mg polyoxyl-50-stearate (Myrj 53) ad 1 mL Aqua p.i.
Doses:
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. No compound-related findings were observed at clinical observations. The body weight gain in one out 3 males was slightly reduced. Necropsy revealed a partly brownish discoloration of the lung and a diminished size of seminal vesicle in male animals and a diminished size of uterus and ovaries in female animals.

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities and clinical signs. The only effects observed were a slight depression of body weight gain and minor alterations in lung and genital organs at necrospsy. 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:
August 2002
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:
Considering the new approach to acute toxicity testing of chemicals described in OECD guideline no.423
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Shoe: WIST (SPF)
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
physiological saline
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.

No animal died in the course of the study. No clinical findings were observed after single dermal administration of 2000 mg/kg. In the first week after treatment, a decrease in body weight gain or a body weight loss was observed in both sexes, which was not fully compensated until day 14. Autopsy revealed no compound-related findings.

Executive summary:

The dermal administration of 2000 mg/kg caused a decrease in body weight in both, male and female rats, but no other signs of toxicity. According to OECD TG 402 taking into consideration the approach described in OECD guideline no. 423 the dermal LD50 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

Additional information

A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities and clinical signs. The only effects observed were a slight depression of body weight gain and minor alterations in lung and genital organs at necrospsy. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.

The dermal administration of 2000 mg/kg caused a decrease in body weight in both, male and female rats, but no other signs of toxicity. According to OECD TG 402 the dermal LD50 is therefore > 2000 mg/kg body weight.


Justification for selection of acute toxicity – oral endpoint
Only one 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.