Pregna-1,4,6-triene-3,20-dione, 17-(acetyloxy)-

Endpoint summary

Description of key information

Skin irritation (Rat): not irritating to skin [Schering AG, Report No. X112 -draft-, 1996-09-26]

Eye irritation (Rabbit, OECD TG 405): not irritating to the eye [Schering AG, Report No. X144 -draft-, 1996-08-22]

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Principles of method if other than guideline:

Combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume1.0-1.1 ml) to male and female rats; semi-occlusive exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 30-60 min after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.

GLP compliance:

yes

Species:

rat

Strain:

Wistar

Type of coverage:

occlusive

Controls:

no

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3 males and 3 females

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Interpretation of results:

GHS criteria not met

Conclusions:

the test item is not irritating to skin

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted. The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of this endpoint.

Approximately 209 mg/male rat and 192 mg/female rat was applied as a paste on the skin and left for 24 hours under occlusive conditions. Subsequently the bandage and the test substance was removed, and the skin areas were assessed according to the system recommended in directive 67/548/EEC. The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

GLP compliance:

yes

Specific details on test material used for the study:

Chemical name: 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
ZK no.: 5560
Batch no.: 25031900
CAS no.: 002668-75-9
Purity: >77% (according to certificate of analysis no.: 92/8145, dated 24 Nov. 95 and re-analysis report 976014, dated 17.07.97)

Species:

rabbit

Strain:

New Zealand White

Controls:

other: The left eye, which remained untreated, served as control.

Duration of treatment / exposure:

test substance remained in the eye - eye was not rinsed

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

2 males and 2 females

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 24h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

A single application of 0.1 ml undiluted test substance into the conjunctival sac led to slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the eye.

Executive summary:

The single applictaion of 0.1 ml undiluted test substance into the eye of 4 rabbits results in slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings. The scores relevant for classification according to Regulation (EC) No 1272/2008 were for the time-points 24, 48 and 72 hours 0 for cornea, iris and chemosis and 0.7 at maximum for conjunctiva/redness.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A combined study on acute dermal toxicity and on local tolerance was conducted. The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion.

Approximately 209 mg/male rat and 192 mg/female rat was applied as a paste on the skin and left for 24 hours under occlusive conditions. Subsequently the bandage and the test substance was removed, and the skin areas were assessed according to the system recommended in directive 67/548/EEC. The mean values of findings (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

The single applictaion of 0.1 ml undiluted test substance into the eye of 4 rabbits results in slight to moderate, occasionally severe reddening, swelling and blood vessel injection at the conjunctivae predominantly on the application day. From days 2 (2 animals), 3 and 4 onwards, the animals were without findings. The scores relevant for classification according to Regulation (EC) No 1272/2008 were for the time-points 24, 48 and 72 hours 0 for cornea, iris and chemosis and 0.7 at maximum for conjunctiva/redness.

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 warranted.