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Administrative data

Description of key information

The source substance is found to be a mild sensitiser in the GPMT assay, in which it was tested using a challenge with dyed textile. In the non-standard Maurer optimization study, the substance was found to possess skin sensitising potential.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: The optimization test similar to the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
None
Specific details on test material used for the study:
None
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals:
The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright white strain bred on the premises and weighing between 350 to 400 grams. The animals were housed individually in Macrolon cages, type 3, kept at a constant room temperature of 22 +/- 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. The animals received ad libitum standard guinea pig pellets - NAFAG, No. 830, Gossau SG - supplemented with fresh carrots.
Route:
other: intracutaneous injections
Vehicle:
other: physiological saline
Concentration / amount:
0.1 % solution of FAT 40034/B in physiological saline
Route:
intradermal
Vehicle:
other: physiological saline
Concentration / amount:
0.1 % solution of FAT 40034/B in physiological saline
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
3%
Adequacy of challenge:
other: sub irritant concentration
No. of animals per dose:
The test was performed on groups of 10 male and 10 female guinea pigs.
Details on study design:
Testing procedure:
During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of FAT 40034/B in physiological saline. One control group was treated with the vehicle alone ("negative control").
On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant2:

(vehicle : adjuvant = 1 : 1).

Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of FAT 40034/B in physiological saline was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.

The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured and by multiplication of these values "reaction volume' was obtained (in ul) for each reading from each animal.
The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control").

Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours.
Challenge controls:
None
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
Erythema observed in 13 animals out of 20
Remarks on result:
other: Incidence of positive animals per group after occlusive epicutaneous application
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/B is considered to be skin sensitizing (contact allergenic) in albino guinea-pigs.
Executive summary:

A study was performed to determine the sensitization of FAT 40034 in albino guinea pigs according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of FAT 40034/B in physiological saline. One control group was treated with the vehicle alone. Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded. Intradermal injection of the vehicle alone failed to induce sensitization. Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were seen after both intradermal and epidermal challenge application of FAT 40034/B. FAT 40034/B is therefore considered to possess skin sensitizing (contact allergenic) potential in albino guinea- pigs.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
None
Specific details on test material used for the study:
None
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
The albino guinea pig is the recommended species for skin sensitisation studies.
Animal strain: Pirbright White Strain (Tif: DHP)
Breeder: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
Date of acclimatisation: November 16, 1994

Group Size and Husbandry:
The test was performed on a total of 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively, initially weighing between 311 to 419 g.
The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+/- 3°C, at a relative humidity of 30 to 70% and a 12 hours light cycle day.
The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water. All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office.
The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
dyed textile patch
Day(s)/duration:
1 day
No. of animals per dose:
The test was performed on a total of 10 males and 10 females guinea pigs in the test group and 5 males and 5 females in the control group, respectively
Details on study design:
Test procedure
DAY 0: INDUCTION, intradermal injections: Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5% FAT 40034/E in physiological saline (w/v)
- 5% FAT 40034/E in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline

DAY 8: INDUCTION, epidermal application: In the test group FAT 40034/E was incorporated in physiological saline and applied on a filter-paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours). The control group was treated with the vehicle only.
Test group:
- 50% FAT 40034/E in physiological saline
Control group:
- physiological saline only

DAY 21: Challenge
The test and control group animals were tested on one flank with the dyed textile patch moistened with distilled water, (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).

Test and control group:
- dyed textile patch moistened with distilled water.
Challenge controls:
None
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema observed in 2 animals out of 20.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Erythema observed in 2 animals out of 20.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
30% 2-mercaptobenzoathiazole
No. with + reactions:
12
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30% 2-mercaptobenzothiazole
No. with + reactions:
13
Total no. in group:
20

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034 is not a sensitiser.
Executive summary:

A guinea pig maximisation test was performed to determine the sensitization potential of FAT 40034 according to the OECD Guideline 406. Following the challenge, 10% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. FAT 40034/E is therefore, classified as a mild sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. However, it does not meet the criteria for classification according to CLP (1272/2008) Regulation.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is Reactive Red 24 carrying a methyl group, while the source chemical is Reactive Red 24:1 carrying an ethyl group.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Red 24:1 (CAS# 72829-25-5 / EC# 276-911-4)
Target: Reactive Red 24 (CAS# 70210-20-7 / EC# 274-417-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
textile dyed with substance
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: very slight erythema in 2 animals
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
textile dyed with substance
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: very slight erythema in 2 animals
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
other: very slight to slight erythema
Reading:
other: 1st and 2nd reading
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
30% 2-mercaptobenzothiazole
No. with + reactions:
12
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30% 2-mercaptobenzothiazole
No. with + reactions:
13
Total no. in group:
20
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on two key studies, the substance is classified as a skin sensitiser, category 1B.
Executive summary:

In two key studies, the source substance was tested for its skin sensitising potential.

The first study is a guinea pig maximisation test (GPMT) with 10 males and 10 females in the test group. On day 0, the guinea pigs get intradermal injections with 5% dye in physiological saline. On day 8, the animals are epidermally induced with 50% dye in saline. On day 21, the occlusive challenge took place using a moistened (with water) textile patch which was dyed with the dye. After 24h, the dressings were removed and 24h and 48h later, challenge reactions were scored according to Draize. Two animals showed very slight erythema. So only 10% of the guinea pigs showed a skin reaction after the challenge with the dyed textile patch. According to the classification criteria of CLP, this is not sufficient to classify for skin sensitisation.

The second study is a Maurer optimization test with 10 males and 10 females in the test group. During the induction period of 3 weeks, animals received an intradermal injection of 0.1% dye in physiological saline, every second day (except weekends). In the 2nd and 3rd week, complete Freund Bacto Adjuvant was added to the dye solution (saline: adjuvant = 1:1). Two weeks after the last induction injection, animals received a challenge injection of 0.1% dye in saline. Ten days later, an occlusive challenge took place for 24h using a subirritant dose of the dye (3% in vaseline). After the intradermal challenge, all 20 animals showed an allergic response. After the epicutaneous challenge, 13 animals showed very slight to slight erythema (i.e. 65%). Although the Maurer optimization method is not a standard method according to CLP for determination of the skin sensitising potential, the high response after epicutaneous exposure warrants a classification as skin sensitiser.

In conclusion: given the fact that a piece of textile dyed with the dye provides a response (10%) at all in the GPMT study, and given the high response in the non-standard Maurer optimization study, the substance will be classified as Skin Sensitising Category 1B (in accordance with CLP). The structurally related target substance will be classified the same.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In two key studies, the source substance was tested for its skin sensitising potential.

The first study is a guinea pig maximisation test (GPMT) with 10 males and 10 females in the test group. On day 0, the guinea pigs get intradermal injections with 5% dye in physiological saline. On day 8, the animals are epidermally induced with 50% dye in saline. On day 21, the occlusive challenge took place using a moistened (with water) textile patch which was dyed with the dye. After 24h, the dressings were removed and 24h and 48h later, challenge reactions were scored according to Draize. Two animals showed very slight erythema. So only 10% of the guinea pigs showed a skin reaction after the challenge with the dyed textile patch.

The second study is a Maurer optimization test with 10 males and 10 females in the test group. During the induction period of 3 weeks, animals received an intradermal injection of 0.1% dye in physiological saline, every second day (except weekends). In the 2nd and 3rd week, complete Freund Bacto Adjuvant was added to the dye solution (saline: adjuvant = 1:1). Two weeks after the last induction injection, animals received a challenge injection of 0.1% dye in saline. Ten days later, an occlusive challenge took place for 24h using a subirritant dose of the dye (3% in vaseline). After the intradermal challenge, all 20 animals showed an allergic response. After the epicutaneous challenge, 13 animals showed very slight to slight erythema (i.e. 65%).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In two key studies, the source substance was tested for its skin sensitising potential.

In the guinea pig maximisation test (GPMT) only 10% of the guinea pigs showed a skin reaction after the challenge with the dyed textile patch. According to the classification criteria of CLP, this is not sufficient to classify for skin sensitisation.

In the Maurer optimization test, all 20 animals showed an allergic response after the intradermal challenge. After the epicutaneous challenge, 13 animals showed very slight to slight erythema (i.e. 65%). Although the Maurer optimization method is not a standard method according to CLP for determination of the skin sensitising potential, the high response after epicutaneous exposure warrants a classification as skin sensitiser.

In conclusion: given the fact that a piece of textile dyed with the dye provides a response (10%) at all in the GPMT study, and given the high response in the non-standard Maurer optimization study, the substance will be classified as Skin Sensitising Category 1B (in accordance with CLP). The structurally related target substance will be classified the same.