Pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-chloro-1-(chloromethyl)-, (1.alpha.)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July to August 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

(1R,3aS,3bR,9S,9aS,9bS,11aS)-1-acetyl-5-chloro-9-(chloromethyl)-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl acetate

EC Number:

605-617-4

Cas Number:

17183-98-1

Molecular formula:

C24 H30 Cl2 O4

IUPAC Name:

(1R,3aS,3bR,9S,9aS,9bS,11aS)-1-acetyl-5-chloro-9-(chloromethyl)-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl acetate

Test animals

Species:

rat

Strain:

Wistar

Test system

Type of coverage:

semiocclusive

Controls:

no

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3/sex

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

No mortalities occurred. No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.

Any other information on results incl. tables

Local findings:

Test compound ZK 10882 (2000 mg/kg)		Animal number and sex
Location (finding)	Time-point after end of exposure	84M	85M	86M	96F	97F	98F
Reddening and scab formation	30 -60 min*	0	0	0	0	0	0
	24 hours	0	0	0	0	0	0
	48 hours	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0
Individual mean values:		0	0	0	0	0	0
Mean value of all animals:							0
Swellings	30 -60 min*	0	0	0	0	0	0
	24 hours	0	0	0	0	0	0
	48 hours	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0
Individual mean values		0	0	0	0	0	0
Mean values of all animals							0

* not included in calculations of mean values

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not cause local skin irritation.

Executive summary:

A single dermal administration of 6 -Chlor-Chlormethyldien (ZK 10882) to male and female rats at the dose of 2000 mg/kg (corresponding to 206-228 mg ZK 10882/male animal and 196-210 mg ZK 10882/female animal) was tolerated without any mortality.

The test substance was tolerated without any local skin irritations. The mean values of findings (at 24, 48 and 72 h) were 0 for swelling, reddening and scab formation.

No compound-related findings were observed with regard to local and clinical observation, determination of body weight and necropsy examination.