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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:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Justification for non-LLNA method:
Study predates LLNA REACH requirements

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Challenge
Route:
epicutaneous, occlusive

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
20 %
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
Slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Slight erythema.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
Slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
20 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
Slight to well-defined erythema with or without slight oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Slight to well-defined erythema with or without slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
Slight to well-defined erythema with or without slight oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Slight to well-defined erythema with or without slight oedema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
20 %
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
Dryness and sloughing of the epidermis
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20 %. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: Dryness and sloughing of the epidermis .
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
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.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

7.4.1.2: Dermal reactions observed after the challenge application:

Group

Animal number

E=Erythema

O =Oedema

Skin reaction (hour after removal of dressing)

Results

Positive (+)

Negative (-)

Inconclusive (±)

24 hours

48 hours

A

P

A

P

Control group

1990

E

0

0

1*

0

 

O

0

0

0

0

1991

E

0

0

0

0

O

0

0

0

0

1992

E

0

0

0

0

O

0

0

0

0

1993

E

0

0

0

0

O

0

0

0

0

1994

E

0

0

0

0

O

0

0

0

0

Treated group

1995

E

1

1

1

1

+

O

0

0

1

1

1996

E

0

0

0

0

-

O

0

0

0

0

1997

E

1

1

2

2

+

O

0

0

1

1

1998

E

0

0

0

0

-

O

0

0

0

0

1999

E

0

0

0

1

-

O

0

0

0

0

2000

E

0

0

2Td

2*

+

O

0

0

1

1

2001

E

1

1

2

2

+

O

0

0

1

1

2002

E

0

0

0

0

-

O

0

0

0

0

2003

E

0

0

1

0

-

O

0

0

0

0

2004

E

1

1

1

2

+

O

0

0

0

1

* Dryness and sloughing of the epidermis

Td Thickening, dryness and sloughing of the epidermis

A Anterior site, exposed to the test item, 20% w/v in vehicle

P Posterior site, exposed to the test item, 10% w/v in vehicle

Applicant's summary and conclusion