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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 2 June 2005 and 9 July 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
An historical non-LLNA in vivo study is available and in this case it is not justifiable to perform another in vivo study. ECHA guidance indicates that existing data of good quality deriving from such tests will be acceptable and will, if providing clear results, preclude the need for further in vivo testing.

Test material

Constituent 1
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were received from Hilltop Lab Animals, and were 8-9 weeks old at study initiation (males - 354 to 446 grams; females - 315 to 374 grams). Animals were individually housed, and maintained on diet & water ad libitum. The acclimation period was 4 weeks before study initiation. Deviations in an animal room temperature and relative humiditywere noted [ 68-75 deg. F (20-24 deg. C) and 42-74%, respectively] vs. the preferred ranges [63-73 deg. F (17-23 deg C) and 30-70%, respectively]. Also the range-finding 24-hour scoring interval was conducted outside the the acceptable range for a 24-hour scoring interval. However, these occurrences were considered to have no adverse impact on the outcome of the study. The animal housing environment was maintained at 20-24 degrees C, 42-74% humidity, and a 12 hour light/dark cycle. Air changes were 1- 15 per hour. The study was conducted over 35 day period from first induction to rechallenge exposures.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil, USP
Concentration / amount:
75% test material in mineral oil - induction phase; 25% test material in mineral oil - challenge phase; 15% test material in mineral oil - rechallenge phase
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil, USP
Concentration / amount:
75% test material in mineral oil - induction phase; 25% test material in mineral oil - challenge phase; 15% test material in mineral oil - rechallenge phase
No. of animals per dose:
10 males, 10 females in test material groups; five per sex in challenge controls
Details on study design:
RANGE FINDING TESTS: 2 Males, 2 females were subjected to dermal applications of 100, 75, 50, 25 (1st trial), and 25, 10, 5, 2.5% (2nd trial with different animals) test chemical in mineral oil in volume of 0.3 ml in each of 4 sites per animal. All shaved skin treatment sites were occluded. Test sites were scored for irritation at 24 and 48 hrs following dosing. A test material concentration of 75% in mineral oil was considered appropriate for induction based on the observed mild to moderate dermal response. A concentration of 25% was considered appropriate for challange based on the observed minimal irritation. MAIN STUDYIn the induction phase a 75% concentration of the test material in mineral oil was applied to shaven sites on the left side of each guinea pig (10 male and 10 female)ed in the induction phase (day 0). The test material was held in skin contact for 6 hrs after which time, the occlusive materials were removed, and skin sites wiped free of test material. The induction procedure was then repeated on Days 6 and 13. The skin sites of all animals were scored for irritation at 24 & 48 hrs following each induction exposure.In the challenge, following a two week rest period, a 25% concentration of the test material was applied on day 27 to the shaved right side of each test animal (10 males and 10 females) and the challenge control animals (5 males and 5 females) in a manner similar to induction dosing. A second challenge trial, following an approximate one week rest period, was made on day 35 of the study using a dosing solution of 15%. Scoring for irritation was performed at 24 & 48 hrs following the challenge and rechallenge.
Challenge controls:
The control group consisted of 5 animals of each sex. These animals were not dosed with carrier solvent (mineral oi).
Positive control substance(s):
yes
Remarks:
Not concurrently but lab had run positive controls within 6 months of study.

Results and discussion

Positive control results:
Nonconcurrent, Historical Control Data from Study with Hexylcinnamaldehyde (HCA) Mean Induction Scores 5% HCA Historical Control 1st Induction 2nd Induction 3rd Induction24 Hours48 Hours24 Hours48 Hours24 Hours48 Hours1.01.0NA0.71.71.5NA = not available Mean Challenge Scores HCAGroup 2.5% 1.0%24 Hours48 Hours24 Hours48 HoursHCA Test0.80.60.50.4HCA Control0.00.00.00.0

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean score = 0.5
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: 10.0. Clinical observations: Mean score = 0.5.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
Mean score = 1.4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% . No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: Mean score = 1.4.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean score = 0.2
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: 10.0. Clinical observations: Mean score = 0.2.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
Mean score = 0.7
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: Mean score = 0.7.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean score = 0.5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean score = 0.5.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
15%
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
Mean score = 0.7
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: Mean score = 0.7.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Mean score = 0.3
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Mean score = 0.3.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
15%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
Mean score = 0.5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Mean score = 0.5.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material (50% test substance in mineral oil) is classified as a skin sensitizer in accordance with Regulation (EC) No. 1272/2008 based on results in guinea pigs.
Executive summary:

The sensitization potential of the test substance (50% test substance in mineral oil) was evaluated in a guinea pigs (20 per sex for the test group and 10 per sex in the untreated control group) using a modified Buehler design. In the induction phase a 75% concentration of the test material was applied to shaven sites on the left side of each guinea pig (10 male and 10 female) in the induction phase (day 0). The test material was held in skin contact for 6 hrs by an occlusive patch after which time, the test material were removed, and skin sites wiped free of test material. The induction procedure was then repeated on Days 6 and 13. The skin sites of all animals were scored for irritation at 24 & 48 hrs following each induction exposure. In the challenge phase, following a two week rest period, a 25% concentration of the test material was applied on day 27 to the shaved right side of each test animal (10 males and 10 females) and the challenge control animals (5 males and 5 females) in a manner similar to induction dosing. A second challenge trial, following an approximate one week rest period, was made on Day 35 of the study using a dosing solution of 15%. Scoring for irritation was performed at 24 & 48 hrs following the challenge and rechallenge. Following the 25% challenge, dermal scores of 1 to 2 were observed in 19/20 test animals at 24 hours, and scores of 1 were observed in 9/20 at 48 hours. Dermal reactions in the challenge controls consisted of scores of 0 and +/-. Following rechallenge with 15% of the test material in mineral oil dermal scores of 1 were observed in 8/20 and 2/20 at 24 and 48 hours, respectively. Dermal reactions in the rechallenge controls consisted of scores of 0 and +/-. The positive control functioned normally indicating that the study was valid. Based on the results of this study the test material (50% test substance in mineral oil) was considered to be a skin sensitizer.