Reaction mass of 5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium methyl sulphate and 3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium methyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 June, 1980 to 23 June, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)

EC Number:

263-444-6

EC Name:

Diethyl sulphate, compound with N-methyl-N-[4-[(1-methyl-1H-1,2,4-triazol-5-yl)azo]phenyl]benzylamine (1:1)

Cas Number:

62163-53-5

Molecular formula:

C17H18N6.C2H6O4S

IUPAC Name:

diethyl sulfate - N-benzyl-N-methyl-4-[(1-methyl-1H-1,2,4-triazol-5-yl)diazenyl]aniline (1:1)

Test material form:

liquid

Specific details on test material used for the study:

Test material received: May 2, 1980
Additional identification: Physical appearance: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The test was performed on 6 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages numbered by ear tags, were kept at a constant room temperature of 22±2 °C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 females

Details on study design:

Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin.
The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema

based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

No irritation was observed with the intact or the abraded skin. Hence, the primary irritation index was calculated to be 0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 31016/F was found to cause no irritation when applied to intact and abraded rabbit skin.

Executive summary:

Skin irritation potential of FAT 31016/F was evaluated in a study conducted according to the procedure described in the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female adult New Zealand White rabbits bred weighing 2 to 3 kgs. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). No irritation was observed with the intact or the abraded skin. Hence, the primary irritation index was calculated to be 0. Based on the findings of the study, FAT 31016/F was found to cause no irritation when applied to intact and abraded rabbit skin.