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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:
01.08.1988 - 26.08.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test is conducted before LLNA methods were available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 5-N-butylbenzotriazole
EC Number:
404-450-2
EC Name:
Sodium 5-N-butylbenzotriazole
Cas Number:
118685-34-0
Molecular formula:
CCCCc1ccc2c(c1)nnn2[Na]
IUPAC Name:
sodium 5-butyl-1H-1,2,3-benzotriazol-1-ide
Test material form:
solid - liquid: aqueous solution
Details on test material:
Identification: Butyl benzotriazole, sodium salt
Physical state: brown liquid
Purity: 37% aqueous solution
Storage condition: ambient temperature in the dark
Specific details on test material used for the study:
Sample received on 26 July 1988

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at ambient temperature in the dark
- Stability under test conditions: the stability and absorption of the test substance were not determined.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Forty female albino guinea-pigs of the Hartley/Dunkin strain were obtained from D. HaIl, Newchurch, Staffordshire, England. The guinea-pigs were acclimated to the Iaboratory environment for 18 days prior to allocation to the study.
The animals were randomly allocated to two groups:
20 control animals
20 test animals
The guinea-pigs were housed in suspended cages with wire mesh floors. They had free access to tap water and a vitamin C-enriched guinea-pig Diet
F.D.1. Hay was given weekly.
Animal room temperature was approximately 21°C and relative humidity 30-70%.
Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light in each 24 hour period.
AII animals were observed daily for signs of ill health or toxicity

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Based on the results of a preliminary investigation, the following concentration of Butyl benzotriazole, sodium salt 37% solution were selected:
Induction
Intradermal injection: 0.1% v/v water for irrigation
Topical application: 40% v/v in distilled water

Challenge
Topical application: 10% and 5% v/v in distilled water
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Based on the results of a preliminary investigation, the following concentration of Butyl benzotriazole, sodium salt 37% solution were selected:
Induction
Intradermal injection: 0.1% v/v water for irrigation
Topical application: 40% v/v in distilled water

Challenge
Topical application: 10% and 5% v/v in distilled water
No. of animals per dose:
Control animals: 20
Test animals: 20
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

One test animal was killed in extremis during the induction period. Signs of ill health inctuded noisy respiration, gasping, dark

eyes and lethargy. Autopsy revealed complete consolidation of anterior lung lobes with patchy consolidation of posterior lobes and pallor of liver: and kidneys. Death was not considered to be related to treatment.

One test animal was found dead prior to the challenge application. Tthe animal was autolysed and cannibalised and the cause of death could not be determined.

The bandage of a further one test animal came off prematurely. This animal was excluded from the final assessment.

The dermal reactions seen in six test animals were more marked than those seen in the controls.

In one further animal the dermal reactions were slightly more marked but not clearly different, from those seen in the controls.

The dermal response seen in the remaining ten animals was similar to the controls.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Butyl benzotriazole - sodium saIt 37% solution requires Iabelling the risk phrase with R43 "May cause sensitisation by skin contact" in accordance with the Directive 67/548/EEC and Hazardous Statement H317 "May cause an allergie skin reaction" in accordance with the regulation (EC) 1272/2008
Executive summary:

A study was performed to assess the skin sensitisation potential of Butyl benzotriazole - sodium salt 37% solution using the guinea-pig.

The experimental procedure used followed the recommendations of:

1 - Annex V Part B Method B6 of the EEC Directive 79/831/EEC

2 - OECD Guideline for Testing of Chemicals No. 406 "Skin Sensitisation"

Based on the results of a preliminary study , the following dose levels were selected:

Induction:

Intradermal injection: 0.1% v/v in water for irrigation

Topical application: 40%% v/v in distilled water

Challenge

Topical application: 10% and 5% in distilled water

All concentrations are expressed in % v/v of 37% solution

twenty test and twenty control guinea-pigs were used in this study.

In this study, Butyl benzotriazole - sodium salt 37% solution produced evidence of skin sensitisation (delayed contact hypersensitivity) in six test animals.