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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male guinea pigs were induced with the test item by a series of 3 intradermal injections. After a 2 week rest period the animals received the epicutaneous challenge exposure, and following 2 further weeks of rest the animals were rechallenged. After additional 2 weeks, the animals received a challenge exposure with the respective polymer of the test item, which was spiked with the monomer (the test ietm itself). Naive control animals were included into the test.
GLP compliance:
no
Type of study:
other: intradermal induction without adjuvant and epicutaneous challenge
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
No details are given in the study report.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: dimethyl phthalate (intradermal injections) and acetone (topical applications)
Concentration / amount:
1%
Challenge
Route:
epicutaneous, open
Vehicle:
other: dimethyl phthalate (intradermal injections) and acetone (topical applications)
Concentration / amount:
- challenge: 0.01, 0.1, and 1% solution- rechallenge: 0.05, 0.1, 0.5, and 1% solution- challenge with polymer: 50% solution, spiked with 0.01, 0.1, and 1% monomer
No. of animals per dose:
9 males
Details on study design:
RANGE FINDING TESTS: A preliminary primary irritation test was conducted by applying, and lightly rubbing in, a drop (=0.05 mL) each of a 0.25 and 2.5% (v/v) solution of the test item (monomer) in acetone on the shaved intact skin of 10 male albino guinea pigs. Skin reactions were investigated 24 and 48 h after exposure. MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 3 - Exposure period: 3 single intradermal injections- Test groups: 0.1 mL of the test item (monomer) in dimethyl phthalate- Control group: Naive control animals were included into the study. - Site: sacrum- Frequency of applications: one each week over a two week period- Duration: days 0-14- Concentrations: 1%B. CHALLENGE EXPOSURE- No. of exposures: 3 (challenge and rechallenge with monomer (test item), and a second rechallenge with polymer spiked with the monomer)- Day(s) of challenge: 28 (challenge); 42 (rechallenge); 66 (second rechallenge)- Exposure period: no data- Test groups: 1 drop (=0.05 mL) of the test item in acetone- Control group: naive control animals received 1 drop (=0.05 mL) of the test item in acetone- Site: shoulder- Concentrations: 0.01, 0.1, and 1% (challenge); 0.05, 0.1, 0.5, and 1% (rechallenge); 50% polymer spiked with 0.01, 0.1, and 1% monomer (second challenge)- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
Only naive control animals were included into the study.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.01 and 0.1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
5 animals showed moderate erythema, 3 animals showed mild erythema, and 1 animal did not show any skin reactions.
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.01, 0.1, and 1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.01 and 0.1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
7
Total no. in group:
9
Clinical observations:
5 animals showed moderate erythema, 2 animals showed mild erythema, and 2 animals did not show any skin reactions.
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.01, 0.1, and 1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.05 and 0.1 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
4
Total no. in group:
9
Clinical observations:
2 animals showed moderate erythema, 2 animals showed mild erythema, and 5 animals did not show any skin reactions.
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
9
Total no. in group:
9
Clinical observations:
3 animals showed moderate erythema and 6 animals showed mild erythema.
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.05, 0.1, 0.5, and 1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
0.05 and 0.1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
9
Clinical observations:
3 animals showed mild erythema and 6 animals did not show any skin reactions.
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
7
Total no. in group:
9
Clinical observations:
1 animal showed moderate erythema and 8 animals showed mild erythema.
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.05, 0.1, 0.5, and 1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
none stated in the study report

Any other information on results incl. tables

Results of test (ctd.)

Reading

Hours after challenge

Group

Dose level

No. with + reactions

Total no. in group

Clinical observations

second rechallenge

24

test group

50% polymer with 0.01% monomer (test item)

2

9

2 animals showed mild erythema and 7 animals did not show any skin reactions.

second rechallenge

24

test group

50% polymer with 0.1% monomer (test item)

6

9

1 animal showed moderate erythema, 5 animals showed mild erythema, and 2 animals did not show any skin reactions.

second rechallenge

24

test group

50% polymer with 1% monomer (test item)

8

9

1 animal showed erythema plus oedema, 5 animals showed moderate erythema, 2 animals showed mild erythema, and 1 animal did not show any skin reactions.

second rechallenge

24

negative control

50% polymer with 0.01% monomer (test item)

2

9

2 animals showed mild erythema and 7 animals did not show any skin reactions.

second rechallenge

24

negative control

50% polymer with 0. 1% monomer (test item)

6

9

6 animals showed mild erythema and 3 animals did not show any skin reactions.

second rechallenge

24

negative control

50% polymer with 1% monomer (test item)

8

9

8 animals showed mild erythema and 1 animal did not show any skin reactions.

second rechallenge

48

test group

50% polymer with 0.01% monomer (test item)

3

9

3 animals showed mild erythema and 6 animals did not show any skin reactions.

second rechallenge

48

test group

50% polymer with 0. 1% monomer (test item)

6

 9

1 animal showed moderate erythema, 5 animals showed mild erythema, and 3 animals did not show any skin reactions.

second rechallenge

48

test group

50% polymer with 1% monomer (test item)

7

9

2 animals showed moderate erythema, 5 animals showed mild erythema, and 2 animals did not show any skin reactions.

second rechallenge

48

negative control

50% polymer with 0.01% monomer (test item)

1

9

1 animal showed mild erythema and 8 animals did not show any skin reactions.

second rechallenge

48

negative control

50% polymer with 0. 1% monomer (test item)

6

9

6 animals showed mild erythema and 3 animals did not show any skin reactions.

second rechallenge

48

negative control

50% polymer with 1% monomer (test item)

7

9

1 animal showed moderate erythema, 6 animals showed mild erythema, and 2 animals did not show any skin reactions.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 1A (H317) according to Regulation (EC) No 1272/2008