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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
Study period:
23 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Only 10 test and 5 control animals were used, induction applications were performed on days 1-9 but not on days 13-15.
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
The in vivo Buehler test was performed before REACh came into force and LLNA method was established.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Dechlorane Plus 25, no further details reported.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details reported

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10% for induction and challenge
Challenge
No.:
#10
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10% for induction and challenge
No. of animals per dose:
10 test animals and 5 controls animals, for pretest 2 animals each for 0.1%, 1.0% and 10% concentrations to evaluate irritation
Details on study design:
In a pretest, Dechlorane Plus 25 was not irritating in groups of 2 animals treated with 0.1, 1.0, and 10% suspension. In the main test, 10 test animals and 5 control animals were initiated with 10% Dechlorane Plus 25 occlusively daily for 9 days, 5 hours per day. Two weeks later, challenge was performe d with 10% Dechlorane Plus 25 epidermally occlusively for 5 hours and reactions recorded at 24 and 48 hours after application.
Challenge controls:
Control animals (5 guinea pigs) were challenged with 10% Dechlorane Plus 25 occlusively for 5 hours but not initiated.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not sensitizing upon epicutaneous induction and challenge. In accordance with the provisions of regulation 1272/2008, Annex I, 3.4, Dechlorane Plus is not classified as sensitising.
Executive summary:

Dechlorane Plus 25 was tested in the Buehler test in guinea pigs for contact sensitization potential. Only 10 test animals and 5 control animals were used. Initiation was performed with 10% test substance applied occlusively for 5 hours per day for 9 days. Challenge was performed with 10% Dechlorane Plus 25 for 5 hours occlusively at 2 weeks after the end of the initiation. Control animals were not initiated and only challenged. No skin reaction was observed in any animal at any time point during induction and challenge. Dechlorane Plus 25 was not contact sensitizing in this study.