Pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From March 07 to April 17, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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

Justification for non-LLNA method:

A LLNA study has not been conducted because adequate data from a guinea pig Maximisation test are already available.

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Red 195 - Similar Substance 01

IUPAC Name:

Reactive Red 195 - Similar Substance 01

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

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: 267 to 315 g
- Housing: 5/cage
- Diet: Altromin 3112 guinea pig maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From March 17 to April 17, 1992

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Concentration / amount:

Concentration of test material and vehicle used at induction: a) Intradermal: 5 % in 0.9 % NaCl-solution / Freund's adjuvant b) Dermal: 25 % in 0.9 % NaCl-solution Concentration of test material and vehicle used for each challenge: a) 25 % in 0.9 % NaCl-solution

Challenge

Route:

epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

Concentration of test material and vehicle used at induction: a) Intradermal: 5 % in 0.9 % NaCl-solution / Freund's adjuvant b) Dermal: 25 % in 0.9 % NaCl-solution Concentration of test material and vehicle used for each challenge: a) 25 % in 0.9 % NaCl-solution

No. of animals per dose:

Determination of primary non-irritating concentration: 6 - Determination of the intradermal tolerance: 3 - Number of animals in attending group: 5 - Number of animals in test group: 10 - Number of animals in negative control group: 5

Details on study design:

RANGE FINDING TESTS:
- Determination of primary non-irritating concentration: dermal-occlusive exposure for 24 hours - 3 concentrations (25 %, 5 %, 1 %)
- Determination of the intradermal tolerance: intradermal injection: 2 x 3 concentrations (5 %, 1 %, 0.2 %)

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
- Exposure period: Injection on Day 1, observation Day 1 to Day 8
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 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: TS + water
- Control group: 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 25 % TS would not lead to dermal irritation in animals pre-treated with 50 % FCA.

Positive control substance(s):

yes

Remarks:

bi-annual validation of assay

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin slightly reddish stained by TS.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin slightly reddish stained by TS.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: skin slightly reddish stained by TS.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

25%

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

skin slightly reddish stained by TS

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: skin slightly reddish stained by TS.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not sensitising

Executive summary:

Method

Testing for sensitizing properties of the test substance was performed in female Guinea pigs according to the OECD 406 (method of MAGNUSSON &KLIGMAN).

Intradermal induction was performed using 5 % of the test substance in isotonic saline. Dermal induction and challenge treatment were carried out with 25 % of the test substance in isotonic saline.

Results

Under the conditions of the present study, none of the ten tested animals showed a positive skin response after the challenge procedure.

Conclusions

Based on the results of this study there is no evidence for sensitizing properties of the test substance.