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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November - December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with GLP, however no EU test guidance is referenced within the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buehler E V (1965).
Deviations:
no
Principles of method if other than guideline:
No EU test guideline referenced within the study report; however the method is specified as based on the Buehler method. Examination of the report indicates that this is equivalent to OECD Guideline 406 (Skin Sensitisation), the Buehler method.
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
EC Number:
413-550-5
EC Name:
Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
Cas Number:
142068-96-0
Molecular formula:
Hill formula: C53H28Cl2N14Na8O26S8
IUPAC Name:
octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
Details on test material:
The test sample (reference: NBY 405/74) was received as a dark brown powder. It was sent for testing from ICI ' Specialties, Blackley, Manchester, UK, A certificate of analysis (reference: 9108127, dated 8 August 1991) stated that the test sample contained 71,6% w/w substance H112339. From information supplied by the sponsor the test sample was used within the stated expiry date, The test sample was given the CTL reference number Y07719/Q01 and was tested either as a paste or a solution in deionised water.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Barriered Animal Breeding Unit, ICI Pharmaceuticals
- Age at study initiation: Young adults
- Weight at study initiation: 391-556g
- Housing: The guinea pigs were housed individually in suspended cages (32.5cm x 37.5cm x 23cm), The cage was constructed from stainless steel with two solid sheet sides, with the front, floor and rear being wire mesh.
- Diet (e.g. ad libitum): RGP Diet, ad libitum
- Water (e.g. ad libitum): via an automatic system, ad libitum
- Acclimation period: minimum of six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19(±2°C)
- Humidity (%): 55 (±15%)
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): controlled by a time switch to give alternate periods of 12 hours of artificial Ifght and 12 hours of darkness.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
SIGHTING STUDY
Challange Stage: 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water
Induction stage: 75% and 30% w/v preparation

MAIN STUDY
Induction: either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (control animals).
Challange: Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0.1-0.2ml of a liquid or 100-200mg of a paste)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
SIGHTING STUDY
Challange Stage: 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water
Induction stage: 75% and 30% w/v preparation

MAIN STUDY
Induction: either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (control animals).
Challange: Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0.1-0.2ml of a liquid or 100-200mg of a paste)
No. of animals per dose:
A group of thirty female guinea pigs was used for the main study, twenty test and ten control
Details on study design:
The sensitisation potential of the formulation was assessed using a method based on that described by Buehler (1965).

Each animal was given a number, unique within the study, which was written both on a small area of clipped, flank, using a black waterproof marker-pen, and on the cage card. The bodyweight of each animal was recorded at the start and end of the study.

Sighting Study; The dose levels for the induction and challenge stages of this study were determined by a sighting study.

Challenge Stage

The test sample as. a 75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water was applied to each of two guinea pigs, as described in the main study. The test sample stained the skin and prevented a full assessment of skin irritation. As no overt signs of irritation were observed at any concentration, animals in the main study were challenged with all concentrations tested in the sighting study.
Induction Stage

With reference to the results of the challenge 'sighting' stage, two concentrations of the test sample (a 75% and 30% w/v preparation) were applied to each of two female guinea pigs as described in the main study, except that they were applied to the flanks not the scapular region. The test sample stained the skin and prevented the assessment of skin irritation. As no signs of irritation were visible at any concentration, animals in the main study were induced with a 75% w/v preparation of the test sample in deionised water.
Main Study: A group of thirty female guinea pigs was used for the main study, twenty test and ten control. The study involved two main procedures, the potential induction of an immune response and a challenge of that response.

Induction

An area approximately 5cm x 5cm on the scapular region of each animal was clipped free of hair with a pair of veterinary clippers and treated with a topical application of. either a 75% w/v preparation (approximately 400mg) (test-group) or approximately 0.4ml of deionised water only (controlanimals). The preparation was applied to a lint patch (approximate size 2cm x 2cm) which was covered with adhesive tape, and held in place by an adhesive elastic bandage (approximate size 20-3Qcm x 5cm) secured by a piece of PVC tape.

This occlusive dressing was left in place for approximately six hours. The induction procedure was repeated at the Same site during the next two weeks, giving a total of three six-hour exposures. The interval between each exposure was 7 days. Clinical observations were noted approximately 1 day after the removal of each patch and before application of each subsequent patch. The animals were re-clipped prior to the application of the formulation.

The animals were left untreated for two weeks after the final induction exposure, prior to challenge.

Challenge

An area approximately 15cm x 5cm on both flanks of each animal was clipped free of hair with a pair of veterinary clippers. An occlusive dressing was prepared which consisted of two lint patches (approximate size 1cm x 2cm) stitched to a piece of rubber sheeting (approximate size 5cm x 12cm),

Preparations (75%, 30%, 10% and 3% w/v) of the test sample in deionised water (approximately 0,1-0.2ml of a liquid or 100-20Qmg of a paste) were each applied to one of four lint patches. The dressings were placed on to the guinea pig so that-the 75% w/v preparation was on the top left shorn flank, the 30% w/v preparation was on the bottom left shorn flank, the 10% w/v preparation was on the top right shorn flank and the 3% w/v preparation was on the bottom right shorn flank. The dressing was held in place by adhesive impermeable polyethylene tape (approximate size 30cm x 7.5cm).

The patches were left in position for approximately six hours. The dressings were then cut, using blunt-tipped scissors, removed and discarded. The positions of the application sites were identified using a black waterproof marker pen.
Erythematous reactions were quantified and recorded, using a four point scale approximately 1 and 2 days after removal of the dressings. When necessary the animals were re-clipped prior to the 1 day reading.


To classify the sensitisation response, the percentage of the control animals that responded was subtracted from the percentage of test animals that responded and the net response was compared to the allocated scale




Formaldehyde (Positive Control): The sensitising potential of a 40% w/v aqueous formaldehyde solution was assessed using a method based on that described by Buehler (1965).

The solution was applied as a 30% w/v dilution in deionised water for both the induction and challenge phases.
Challenge controls:
75%, 30%, 10% and 3% w/v preparation of the test sample in deionised water was applied to each of two guinea pigs
Positive control substance(s):
yes
Remarks:
Formaldehyde

Study design: in vivo (LLNA)

Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
Not applicable

Results and discussion

Positive control results:
Signs of moderate irritation, including scabbing, thickening of the skin, desquamation, oedema and erythema were seen in test animals during the induction phase of the study. No signs of skin irritation were seen in any of the control animals.

Following challenge with a 30% w/v preparation of a formaldehyde solution (40% w/v in water), scattered mild redness to moderate diffuse redness was seen in nineteen out of twenty test animals. Scattered mild redness was observed in four out of ten control animals. The net percentage response was calculated to be 55%.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 20/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 20/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 20/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 20/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 20/20 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 8/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 8/20 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 9/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 9/20 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 17/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 17/20 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Test sample stained the skin 17/20 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Test sample stained the skin 17/20 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 10/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 10/10 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 10/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 10/10 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 5/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 5/10 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 4/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 4/10 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 3/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 3/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 3/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Test sample stained the skin 3/10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Test sample stained the skin 3/10 animals.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

MAIN STUDY – CHALLENGE RESULTS

 

Challenge concentrations: 75% w/v in deionised water

                                       30% w/v in deionised water

                                   10% w/v in deionised water

                                        3% w/v in deionised water

 

Animal Number

Test Animals

75% w/v

30% w/v

10% w/v

3% w/v

24h

48h

24h

48h

24h

48h

24h

48h

61

*0

*0

0

0

*0

*0

**

**

62

*0

*0

0

0

**

*0

0

0

63

*0

*0

*0

*0

*0

*0

*0

*0

64

*0

*0

0

0

**

**

**

**

65

*0

*0

0

0

0

0

**

**

66

*0

*0

0

0

0

0

*0

*0

67

*0

*0

0

0

0

0

*0

*0

68

*0

*0

0

0

0

0

*0

*0

69

*0

*0

0

0

0

0

0

0

70

*0

*0

0

0

0

0

**

**

71

*0

*0

*0

*0

*0

*0

*0

*0

72

*0

*0

0

0

0

0

*0

*0

73

*0

*0

0

0

0

0

0

0

74

*0

*0

0

0

0

0

*0

*0

75

*0

*0

*0

*0

*0

*0

*0

*0

76

*0

*0

0

*0

0

*0

*0

*0

77

*0

*0

0

0

0

0

*0

*0

78

**

**

*0

*0

0

0

**

**

79

*0

*0

0

0

*0

*0

*0

*0

80

*0

*0

0

0

*0

*0

*0

*0

**=test sample stained the skin and obscured the application site

*0= no reaction, test sample stained the skin but all responses could be assessed

 

Animal Number

Control Animals

75% w/v

30% w/v

10% w/v

3% w/v

24h

48h

24h

48h

24h

48h

24h

48h

81

*0

*0

*0

*0

0

0

0

0

82

*0

*0

0

0

0

0

0

0

83

*0

*0

0

0

*0

*0

**

**

84

*0

*0

0

0

0

0

0

0

85

*0

*0

*0

*0

0

0

0

0

86

*0

*0

0

0

0

0

0

0

87

*0

*0

*0

0

0

0

0

0

88

*0

*0

*0

*0

*0

*0

*0

*0

89

*0

*0

0

0

0

0

0

0

4584

*0

*0

*0

*0

*0

*0

**

*0

**=test sample stained the skin and obscured the application site

*0= no reaction, test sample stained the skin but all responses could be assessed

 

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The sensitisatlon potential of Substance H112339 was assessed using a method based on that described by Buehler (1965).

Challenge of previously induced guinea pigs with either a 75%, 30-%, 10% or a 33; w/v preparation of the test sample in deionised water did not elicit a sensitisation response.

In conclusion. Substance H112339 was not a sensitiser under the conditions of the test.
Executive summary:

Study conducted in compliance with GLP. No EU test standard is referenced within the study report, however the study was conducted to the Buehler method and is considered

The substance is not sensitising under the test conditions.