(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17β-ol

Endpoint summary

Description of key information

LD50 oral (rat): > 2000 mg/kg bw [Treher 1994]
LD50 dermal (rat): > 2000 mg/kg bw [Kurth 1994]

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 July 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:

no

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:

water

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.The single oral application of 2 g/kg of test substance was tolerated by 2 of 3 animals of each sex without any clinical findings. One male and one female animal showed slight apathy on the application day.All animals were without clinical symptoms from day 2 onwards. The body weight gain on days 7 and 14 was within or slightly above 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 the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy was observed in one male and one female on the application day. 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 July to August 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar 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: HAN: WIST (SPF)

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

other: 0.9% /w/v) NaCl-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.

No animal died in the course of the study. A single dermal application of 2000 mg/kg was tolerated without compound-related findings. 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. No compound- related clinical findings could be detected at the end of the study on day 14. Autopsy revealed no compound-related findings.

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal 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

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, effects on body weight gain and gross pathological findings. Slight apathy wasobserved in one male and one female on the application day. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance 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.