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Diss Factsheets

Administrative data

Description of key information

According to an OECD TG 406 compliant study in the guinea pig, the test item was found to be sensitising to the skin (reference 7.4.1 -1).

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:
25 September 1996 - 03 February 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1990 when the LLNA was not an established test method yet.
Species:
guinea pig
Strain:
Hartley
Remarks:
Crl:(HA)BR
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kisslegg
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 310 - 365 g
- Housing: 2 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 47 - 75%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
- IN-LIFE DATES: From: To: 29 October 1996 - 06 December 1996
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
5 g/L
Day(s)/duration:
0 / single application
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
250 g/L
Day(s)/duration:
8 / 48 hours
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
250 g/L
Day(s)/duration:
22 / 24 hours
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
25 g/L
Day(s)/duration:
36 / 24 hours
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
RANGE FINDING TESTS:
1. Vehicle intradermal: undiluted
2. Test item:
- intradermal: 1, 5, 10, 25 and 50 g/L
- topical 10, 50, 100 and 250 g/L
- topical with FCA: 10, 50, 100 and 250 g/L

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal injection, topical application, no washing
- Test groups: 2
- Control group: 2
- Site: back
- Frequency of applications: single application
- Duration: 48 hours
- Concentrations: 5 g/L, 250 g/L

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22 and 36
- Exposure period: topical application, no washing
- Test groups: 2
- Control group: 2
- Site: right or left flank
- Concentrations: 250 g/L (1st challenge) and 25 g/L (2nd challenge)
- Evaluation (hr after challenge): 24 and 48 hours after challenge
Challenge controls:
yes
Positive control substance(s):
no
Remarks:
no concurrent positive controls, but positive control data from parallel studies reported
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
7
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
4
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5 %
No. with + reactions:
9
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5 %
No. with + reactions:
10
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
2.5%
No. with + reactions:
2
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
2.5%
No. with + reactions:
3
Total no. in group:
10

Maximum concentration not causing irritating effects in preliminary test: 25 %

Signs of irritation during induction:
Typical signs of an irritation after injection of Freund's Adjuvans (swelling, rednes, necrosis, scaling).

After topical application: Swelling, redness, scaling.

Evidence of sensitisation of each challenge concentration:
slight edema, erythema

Other observations:
none

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Based on the findings of this study, the test item is considered to have skin sensitising properties.
Executive summary:

A guinea-pig maximisation test according to Magnusson and Kligman (OECD 406) was performed to identify the skin sensitising potential of the test item. 10 females in the negative control group (group 1) and 20 females in the test item group (group 2) were investigated.

Induction included intradermal injection of the test item at a concentration of 5 g/L (with and without Freund's complete adjuvant) on day 1 and topical application of the test item at a concentration of 250 g/L on day 8. Challenge I by topical application of the test item was performed with a concentration of 250 g/L. Due to questionable results after the first challenge, a second challenge (challenge II) with a lower concentration of 25 g/L was considered to be necessary two weeks later.

After challenge I positive reactions (erythema) were observed in 8 of 20 animals (40%). Challenge II revealed positive reactions in the treated areas in 10 of 20 animals (50%). The test item was considered a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitisation

A guinea-pig maximisation test according to Magnusson and Kligman (OECD 406) was performed to identify the skin sensitising potential of the test item. 10 females in the negative control group (group 1) and 20 females in the test item group (group 2) were investigated.

Induction included intradermal injection of the test item at a concentration of 5 g/L (with and without Freund's complete adjuvant) on day 1 and topical application of the test item at a concentration of 250 g/L on day 8. Challenge I by topical application of the test item was performed with a concentration of 250 g/L. Due to questionable results after the first challenge, a second challenge (challenge II) with a lower concentration of 25 g/L was considered to be necessary two weeks later.

After challenge I positive reactions (erythema) were observed in 8 of 20 animals (40%). Challenge II revealed positive reactions in the treated areas in 10 of 20 animals (50%). The test item was considered a skin sensitiser (reference 7.4.1 -1).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item is classified and labelled as skin sensitiser Cat 1 (H317: "May cause an allergic skin reaction") according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.