17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

Endpoint summary

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.