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Description of key information

acute oral toxicity (rat): LD50 > 2000 mg/kg bw (no mortality)
acute dermal toxicity (rat): LD50 > 2000 mg/kg bw (no mortality)

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:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Cetiol OE
- Physical state: liquid
- Analytical purity: >99.9%
- Lot/batch No.: 7/91
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality was observed.
Mortality:
no mortality
Clinical signs:
other: no effects
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
LD50>2000 mg/kg body weight
Executive summary:

The acute oral toxicity of the test substance was investigated in young adult Wistar rats according to OECD guideline 401. The test article was dissolved in arachidis oil and given orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days, the rats were observed for any signs of reaction. The surviving rats were sacrified at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 was >2000 mg/kg for male and female rats.


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:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
other:
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): C-SAT 080029
- Physical state: liquid
- Analytical purity oder Active matter: 99.1%
- Lot/batch No.: CE72530027
Species:
rat
Strain:
other: CD/Crl:CD (SD)
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality was observed
Mortality:
none
Clinical signs:
other: no changes
Gross pathology:
no changes
Other findings:
no

LD0>2000 mg/kg

Interpretation of results:
GHS criteria not met
Conclusions:
substance not toxic after dermal application
Executive summary:

The study was performed as a limit test according to OECD guideline 402. Wistar rats (5 males and 5 females) were randomly selected for the study. The group was exposed to a single dermal dose of 2000 mg/kg b.w. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two-week observation period the animals were killed and subjected to a gross necropsy examination. All animals survived the application and did not reveal any signs of toxicity. The animals gained the expected body weight. No skin reactions at the application site were observed. No macroscopic findings were observed at necropsy. These results indicate that the test substance has no significant toxic effect in the rat following dermal administration of a single dose at a level of 2000 mg/kg. 

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

Additional information

Acute oral toxicity:

The acute oral toxicity of the test substance was investigated in young adult Wistar rats according to OECD guideline 401. The test article was dissolved in arachidis oil and given orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day in the following 14 days, the rats were observed for any signs of reaction. The surviving rats were sacrified at the end of the observation period and a macroscopic postmortem examination was performed on all rats. The LD50 was >2000 mg/kg for male and female rats.

Based on the reliability and relevance, this study has been used as key study.

Acute dermal toxicity:

A study was performed as a limit test according to OECD guideline 402. Wistar rats (5 males and 5 females) were randomly selected for the study. The group was exposed to a single dermal dose of 2000 mg/kg b.w. for 24 hours followed by an observation period of 14 days. During the study clinical signs of reaction to the treatment were recorded daily. Body weight was recorded once a week. After the two-week observation period the animals were killed and subjected to a gross necropsy examination.All animals survived the application and did not reveal any signs of toxicity. The animals gained the expected body weight. No skin reactions at the application site were observed. No macroscopic findings were observed at necropsy.These results indicate that the test substance has no significant toxic effect in the rat following dermal administration of a single dose at a level of 2000 mg/kg. 

Based on the reliability and relevance, this study has been used as key study.

Acute inhalation toxicity:

Inhalation toxicity has not been evaluated as the predominant exposure route is via the dermal route.

Justification for classification or non-classification

Based on results of the key studies the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).