Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate

Endpoint summary

Description of key information

skin irritation: none

eye irritation: slight

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:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Principles of method if other than guideline:

according to § 1500.41 in Federal Register Vol. 38, No. 187, S. 26019 ov 27.09.73
The procedure followed the standards of that time.

GLP compliance:

no

Specific details on test material used for the study:

Name of test substance given in report: Thermoplastrot BS – Misch-Nr. 07-4264,
Composition given in report: 103,0 Teile Thermoplastrot Lm Fw/400 Stück ber. 100%

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

breeder: M. Gaukler, 6050 Offenbach
mean weight: about 3.0 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: pasted with 50% water

Amount / concentration applied:

about 0.5 g on a patch of about 2.5 x 2.5 cm

Duration of treatment / exposure:

24 hours

Observation period:

up to 8 days after patch removal

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: about 2.5 x 2.5 cm
- Type of wrap if used: patch is covered with a rubberized linnen lobe, fixed and wrapped with a gauze bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
24 hours, 72 hours and 8 days after patch removal

SCORING SYSTEM:
- Method of calculation: scores of 1-4 for reddening and oedema

Irritation parameter:

erythema score

Basis:

animal: 1-6

Time point:

24 h

Remarks on result:

not determinable

Remarks:

due to substance induced staining of the skin

Irritation parameter:

erythema score

Basis:

animal: 1-6

Time point:

other: 72h and 8 days after patch removal

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal: 1-6

Time point:

other: 24h, 72 h and 8 days after patch removal

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Executive summary:

In a skin irritation study performed according to Fed. Reg. 38, no. 187, § 1500.41 (1973) 0.5g of the solid test item pasted with water was applied for 24 hours to the intact skin of the back of 6 rabbits. 24 hour after patch removal erythema could not be evaluated due to a distinct red/brown staining of the skin due to the coloured test item. 72 hours and 8 days after patch removal no indication of erythema was recorded. Oedema was not seen at all scoring times (24h, 72h, 8days). The test item thus did not show irritating effects to the skin of rabbits.

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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

according to Federal Register, Vol. 38, no. 187 (27.09.1973), § 1500.42 and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, p. 51
The procedure followed the standards of that time.

GLP compliance:

no

Specific details on test material used for the study:

Name of test substance given in the report: Thermoplastrot BS – Misch-Nr. 07-4264
composition of test substance given in the report: 103,0 Teile Thermoplastrot Lm Fw/400 Stück ber. 100%

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

breeder: M. Gaukler, 6050 Offenbach, Germany
mean weight: 2.9 kg

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

amount of test item applied is not given in the report; after treatment the eye was tightly kept close

Observation period (in vivo):

24, 48, and 72 hours

Number of animals or in vitro replicates:

6 animals (1 male, 5 females)

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

cornea opacity score

Basis:

animal: 1, 3, 4, 5, 6

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:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks:

at time point 24h all animals showed score 1.0; at 48h 5 animals showed score 1.0 and one animal showed 2.0; at 72h 4 animals showed score 1.0 and 2 animals showed no effects

Irritation parameter:

chemosis score

Basis:

animal: 2, 3, 4, 5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Other effects:

slight lacrimation in some animals 24 and 48h after treatment

Executive summary:

In an eye irritation study performed according to Fed. Reg. 38, no. 187, § 1500.42 (1973) in 1978 the solid test item was applied to the conjunctival sac of one eye of 6 rabbits. The other eye of each animal served as untreated control. The test item led to slight reddening of the conjunctivae in all animals 24 and 48h after treatment and in 4 animals at the time point 72 hours. Slight cornea effects were seen in one animal only at 24 hours and slight chemosis in 4 animals at 24 hours only. In conclusion, the test item led to slight eye irritation in this test.

Additional information

In a skin irritation study performed according to Fed. Reg. 38, no. 187, § 1500.41 (1973) in 1978 the solid test item pasted with water was applied for 24 hours to the intact skin of the back of 6 rabbits. 24 hour after patch removal erythema could not be evaluated due to a distinct red/brown staining of the skin due to the coloured test item. 72 hours and 8 days after patch removal no indication of erythema was recorded. Oedema was not seen at all scoring times (24h, 72h, 8days). The test item thus did not show irritating effects to the skin of rabbits.

In an eye irritation study performed according to Fed. Reg. 38, no. 187, § 1500.42 (1973) in 1978 the solid test item was applied to the conjunctival sac of one eye of 6 rabbits. The other eye of each animal served as untreated control. The test item led to slight reddening of the conjunctivae in all animals 24 and 48h after treatment and in 4 animals at the time point 72 hours. Slight cornea effects were seen in one animal only at 24 hours and slight chemosis in 4 animals at 24 hours only. In conclusion, the test item led to slight eye irritation in this test.

Justification for classification or non-classification

The substance showed no irritation on rabbit's skin and slight irritation to rabbit's eyes. Thus, no classification is warranted for skin and eye irritation.