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Diss Factsheets

Administrative data

Description of key information

Basic Red 046 Methylsulfate was considered to cause no irritation when applied to intact and abraded rabbit skin, however leads to irreversible effects on the eyes.

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:
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
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
Specific details on test material used for the study:
Test material received: May 2, 1980
Additional identification: Physical appearance: liquid
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.
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.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

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.

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.  

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:
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
Qualifier:
according to guideline
Guideline:
other: the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
Test material received May 2, 1980
Additional identification: Physical appearance: liquid
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 6 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals 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 hour light cycle day. The animals had ad libitum access to 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. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 females
Details on study design:
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2.89
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: treated eye not rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: treated eye not rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.89
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: treated eye not rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.22
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: treated eye not rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Treated eye rinsed after 30 seconds
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
2
Reversibility:
not fully reversible within: 7 days for the rabbit with symptoms
Remarks on result:
other: Treated eye rinsed 30 seconds after instillation; 2 out of 3 rabbits had no irritation reaction in iris at any observation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Treated eye rinsed 30 seconds after instillation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.22
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Treated eye rinsed 30 seconds after instillation

Primary irritation index

Time after

exposure

days

mean reaction score

unrinsed eyes (A)

rinsed eyes (B)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

26.7

10

18

11.7

1.7

15.3

2

40

10

18.7

25

3.3

17.3

3

40

10

18.7

30

3.3

17.3

4

46.7

10

18.7

30

3.3

17.2

7

46.7

10

18.7

30

3.3

14.7

subtotal

200.1

50

92.8

126.7

14.9

81.9

total

342.9

223.5

primary irritation index in unrinsed eyes

A = 342.9 : 5 = 68.6

primary irritation index in rinsed eyes

B = 223.5 : 5 = 44.7

effect of rinsing

R = A/B = 68.6/44.7 = 1.5

Scores for individual rabbits

Animal no.s

 

scores

24 h

48 h

72 h

Day 4

Day 5

127

(Unrinsed)

Corneal opacity

3

3

3

4

4

Iris

2

2

2

2

2

Conjunctival

redness

3

3

3

3

3

Chemosis

3

4

4

4

4

128 (Unrinsed)

Corneal opacity

2

3

3

3

3

Iris

2

2

2

2

2

Conjunctival redness

3

2

3

3

3

Chemosis

3

3

3

3

3

129 (Unrinsed)

Corneal opacity

3

3

3

3

3

Iris

2

2

2

2

2

Conjunctival

redness

3

3

3

3

3

Chemosis

3

3

3

3

3

130 (Rinsed)

Corneal opacity

1

1

1

1

1

Iris

0

0

0

0

0

Conjunctiva

2

2

2

2

2

Chemosis

3

3

3

3

2

131 (Rinsed)

Corneal opacity

1

1

1

1

1

Iris

0

0

0

0

0

Conjunctival

redness

2

2

2

2

2

Chemosis

3

3

3

3

2

132 (Rinsed)

Corneal opacity

2

3

4

4

4

Iris

1

2

2

2

2

Conjunctival redness

3

3

3

3

3

Chemosis

3

4

4

4

4
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Instillation of FAT 31016/F in eye, leads to irreversible effects on the eyes.
Executive summary:

Eye irritation potential of FAT 31016/F was evaluated in a study conducted as per the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female New Zealand White rabbits. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥3 for 2 out of 3 rabbits which did not receive rinsing. Also the iris was scored to be =2 in all 3 rabbits which did not receive rinsing. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Skin irritation potential of Basic Red 046 Methylsulfate (FAT 31016/F, purity 36 %) 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. In this study, 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 considered to cause no irritation when applied to intact and abraded rabbit skin.

Eye irritation

Eye irritation potential of Basic Red 046 Methylsulfate (FAT 31016/F, purity 36 %) was evaluated in a study conducted as per the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 6 female New Zealand White rabbits. In this study, the corneal opacity was scored to be ≥3 for 2 out of 3 rabbits which did not receive rinsing. Also the iris was scored to be =2 in all 3 rabbits which did not receive rinsing. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.

Justification for classification or non-classification

Basic Red 046 Methylsulfate does not warrant classification for skin irritation, however needs to be classified as a substance causing irreversible effects on eye (category 1) as per the Regulation EC No. 1272/2008 (CLP) criteria.