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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-06-24 to 1992-12-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
adopted Sept. 19, 1984
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
When this study was performed, the LLNA did not yet exist.
Specific details on test material used for the study:
- Analytical purity: 99%
- Appearance: orange powder
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: approximately six to seven weeks
- Weight at study initiation: 295 to 342 g
- Housing: in groups of ten in suspended metal cages with wire mesh floors
- Diet: vitamin C enriched guinea-pig diet FDl ad libitum
- Water: drinking water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature: approximately 21°C
- Humidity: 30-70%
- Air changes: approximately 15 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period

IN-LIFE DATES: From: 1992-09-16 To: 1992-10-18
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction intradermal injection - 5% w/w in water (maximum practical concentration that could be prepared and dosed intradermally)
Induction topical application - 50% w/w in distilled water
Topical challenge - 50 and 25% w/w in distilled water

From preliminary investigations: 50% w/w in distilled water was the maximum practical concentration and did not give rise to irritating effects.
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
Induction intradermal injection - 5% w/w in water (maximum practical concentration that could be prepared and dosed intradermally)
Induction topical application - 50% w/w in distilled water
Topical challenge - 50 and 25% w/w in distilled water

From preliminary investigations: 50% w/w in distilled water was the maximum practical concentration and did not give rise to irritating effects.
No. of animals per dose:
20 females
Details on study design:
A. INDUCTION EXPOSURE
- intradermal (test animals): three pairs of injections (0.1 mL each) on day 0
1st: FCA 50 : 50 with water for irrigation (Ph. Eur.)
2nd: test item, 5% w/w in water for irrigation.
3rd: test item, 5% w/w in a 50 : 50 mixture of water for irrigation and FCA
- control animals received the same treatment, except test item
- topical: following clipping, 0.2 mL per site of 10% w/w sodium lauryl sulfate was spread over the intradermal injection sites on day 6. On day 7, test item or deionized water was applied to the test item or control groups respectively.
- Exposure period, topical: 48 hours

B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day of challenge: two weeks after the topical induction application
- Exposure period: approximately 24 hours
- Test groups: one test group
- Concentrations: 50% w/w in distilled water and applied to an anterior site on the flank, 25% w/w in distilled water applied in a similar
manner to a posterior site.
- Control group: treated as test item group
- Evaluation: approximately 24, 48 and 72 hours following patch removal
Positive control substance(s):
yes
Remarks:
periodical reliability check (formalin)
Positive control results:
The positive control caused the expected skin reactions, thus, demonstrating the sensitivity of the test system.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% and 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% and 25%
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: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other:
Hours after challenge:
72
Group:
test chemical
Dose level:
50% and 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other:. . Hours after challenge: 72.0. Group: test group. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% and 25%
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: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% and 25%
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: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other:
Hours after challenge:
72
Group:
negative control
Dose level:
50% and 25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 50% and 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Procedure and results

To evaluate the allergic potential of the substance, a skin maximisation test in guinea-pig was perfomed. Ten test and tencontrol guinea-pigs were used in this study. For induction the animals were treated intradermally (5%). 6 days later, topical induction (50%) in the same area was performed after treatment with sodium lauryl sulphate in petrolatum. Control and test animals were challenged topically two weeks after the topical induction application using the test substance, 25 and 50% w/v in distilled water.

No skin reactions or signs of toxicity were recorded. There were no dermal reactions seen in any of the test animals.

Discussion

The test substance did not induce any dermal reactions in test animals. Thus, the test substance is considered to be a non-sensitizer.


Migrated from Short description of key information:
To evaluate the allergic potential of the test substance, a skin maximisation test (EU B.6, GLP) in guinea-pig was perfomed. The test item did not induce any dermal reactions in test animals. Thus, the test substance is considered to be a non-sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

                               Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.