Benzenesulfonic acid, 4-(acetylamino)-2-amino-5-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:2)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 27th, 1988 to July 29th, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

disodium 2-amino-4-acetamido-5-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate

EC Number:

940-436-7

Cas Number:

1354632-48-6

Molecular formula:

C16H18N4O10S3.xNa C16H16N4Na2O10S3 as disodium salt

IUPAC Name:

disodium 2-amino-4-acetamido-5-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Remazol-Goldgelb RNL

In vivo test system

Test animals

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: mean 293 g; range: 241 g to 338 g; n = 15
- Housing: group-housing (5/cage)
- Diet: Altromin ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: ca. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: June 27th, 1988 to July 29th, 1988

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: intradernal: saline; epicutaneous: vaseline

Induction 2

Concentration / amount:

Intradermal: 5%
dermal induction: 25%
dermal challenge: 2.5%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: intradernal: saline; epicutaneous: vaseline

Challenge 2

Concentration / amount:

Intradermal: 5%
dermal induction: 25%
dermal challenge: 2.5%

No. of animals per dose:

Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10

Details on study design:

RANGE FINDING TESTS:

Determination of the primary non-irritant concentration:
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25.0 % Remazol-Goldgelb RNL in vaseline
2.5 % Remazol-Goldgelb RNL in vaseline
0.25 % Remazol-Goldgelb RNL in vaseline
The hair on the left flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema

Determination of the tolerance of intradermal injections:
To determine the tolerance of intradermal injections, each of the following preparations (5.0%, 1.0%, 0.25% in isotonic saline) was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.


MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 5% TS in 0.9% NaCl, 5% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 7
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 25% TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 25%

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: 25% TS + 0.9% NaCl
- Control group: 25% TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

In addition to the control group, 5 further guinea pigs (attending group) were used to confirm that challenge exposure with 2.5% TS would not lead to dermal irritation in animals pre-treated with 50% FCA.

Positive control substance(s):

yes

Remarks:

bi-annually tested

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Results 2

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

2.5%

No. with + reactions:

10

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2.5%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is sensitizing in pirbright white guinea pigs.

Classification: sensitizing

Executive summary:

Testing for sensitizing properties of Remazol Gelb RLN was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN. Intradermal induction was performed using 5% test substance in isotonic saline. Dermal induction and challenge treatment were carried out with 25% and 2.5% test substance in white vaseline.

Based on the results of this study Remazol Gelb RLN showed evidence for sensitizing properties.