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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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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
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.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details reported
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
10% for induction and 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
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
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.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The contact sensitizing potential of fabric impregnated with Dechlorane was tested in rabbits. A possible release of substance from the fabric was not verified.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 6 albino rabbits were applied with the impregnated or the non-impregnated fabric 5 times for 24 hours each occlusively. After a rest period of 10 days, challenge was performed with impregnated fabric for 24 hours under occlusive conditions.
Fifty healthy human volunteers were exposed to impregnated and non-impregnated fabrics 10 times for 24 hours under occlusive conditions, and after a rest period of 11 to 13 days challenge was performed with impregnated fabric for 48 hours under occlusive conditions.
GLP compliance:
no
Type of study:
patch test
Species:
other: rabbit and human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no details reported
Route:
epicutaneous, occlusive
Vehicle:
other: impregnated fabric
Concentration / amount:
not reported
Route:
epicutaneous, occlusive
Vehicle:
other: impregnated fabric
Concentration / amount:
not reported
No. of animals per dose:
6 rabbits and 50 human volunteers
Details on study design:
see above
Challenge controls:
only rabbits as challenge controls, no humans
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no skin reaction in rabbits
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: not reported. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no skin reaction in rabbits.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no skin reaction in rabbits
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: not reported. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no skin reaction in rabbits.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no skin reaction in rabbits
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: not reported. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no skin reaction in rabbits.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no skin reaction in rabbits
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: not reported. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no skin reaction in rabbits.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
no skin reaction in humans
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: not reported. No with. + reactions: 0.0. Total no. in groups: 50.0. Clinical observations: no skin reaction in humans.
Interpretation of results:
other: no reliable result
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Although no signs of irritation or sensitization was observed neither in rabbits nor in humans, this test does not provide a reliable result
Executive summary:

Fabric impregnated with Dechlorane Plus was used to test contact sensitizing properties in rabbits and humans. Groups of 6 rabbits each were applied the impregnated or the nonimpregnated fabric on the skin for 24 hours each under occlusive conditions for 5 times. After a rest period of 10 days, challenge was performed with impregnated fabric by application for 24 hours under occlusive conditions.

A total of 50 human volunteers were applied the impregnated and the nonimpregnated fabric 10 times for 24 hours each under occlusive conditions. After a rest period of 11 -13 days, challenge was performed using impregnated fabric for 24 hours under occlusive conditions. No signs of irritation or sensitization were observed in any animal or any volunteer at any time of the study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No signs of irritation or contact sensitization were observed in 5 control and 10 test guinea pigs at a concentration of 10% used for initiation and for challenge. Dechlorane Plus was essentially non-sensitizing.

Migrated from Short description of key information:

No signs of irritation or contact sensitization were observed in 5 control and 10 test guinea pigs at a concentration of 10% used for initiation and for challenge.

Justification for selection of skin sensitisation endpoint:

Bühler Test according to OECD 406, no other valid test available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on negative findings in two skin sensitisation studies, the substance is not classifiable for skin sensitising properties according to CLP (Regulation EC No 1272/2008). Data on respiratory sensitisation are not available.