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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
Reliability:
2 (reliable with restrictions)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Some temperature and humidity were outside the range. Sodium lauryl sulphate have not been applicated and the test substance concentration was not irritating (70% w/v concentration as the possible maximum soluble concentration) after topical induction.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Principles of method if other than guideline:
Not applicable

Test material

In vivo test system

Test animals

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

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:
negative control
Dose level:
10 % w/v
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 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 % w/v
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 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % w/v
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Dryness and sloughing of the epidermis in 4 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % w/v. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 4 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Dryness and sloughing of the epidermis in 2 animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 % w/v
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: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 % w/v
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: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 % w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Dryness and sloughing of the epidermis in 2 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Dryness and sloughing of the epidermis in 2 animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.

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

Table 7.4.1/1: Dermal reactions observed after the challenge application with E96095

Animal No.

24 Hours

48 Hours

Results

Erythema

Oedema

Erythema

Oedema

 

A

P

A

P

A

P

A

P

-

1735

0

0

0

0

0

0*

0

0

-

1736

0

0

0

0

0

0

0

0

-

1737

0*

0

0

0

0*

0

0

0

-

1738

0

0

0

0

0

0

0

0

-

1739

0

0

0

0

0

0

0

0

-

1740

1*

0*

0

0

0*

0

0

0

±

1741

0

0*

0

0

0

0

0

0

-

1742

0*

0

0

0

0

0

0

0

-

1743

0

0

0

0

0

0

0

0

-

1744

1*

0

0

0

0

0

0

0

±

* Dryness and sloughing of the epidermis

A Anterior site, exposed to E96095, 10 % w/v in Alembicol D

P Posterior site, exposed to E96095, 5 % w/v in Alembicol D

Clinical signs

No sign of toxicity were observed

Bodyweight

Bodyweight increases were recorded for all guinea-pigs over the period of the study

Induction

Intradermal injections:

Necrosis were recorded at sites received Freund's Complete Adjuvant in test and control animals.

Slight irritation was seen in test animals at sites receiving E96095, 5 % w/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.

Topical application:

No erythema was observed in test animals following topical application with E96095, 70 % w/v in Alembicol D.

No erythema was seen in the control guinea-pigs

Challenge

There were no dermal reactions seen in 8 of the 10 test animals or in any of the control animals. The remaining 2 animals gave inconclusive response.

Applicant's summary and conclusion