Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
Not applicable
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Route:
epicutaneous, occlusive
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Dryness of skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Dryness of skin.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Dryness of skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Dryness of skin.
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Table 1: range-finding test by intradermal route

Animal

number

Concentration of the

test item % (w/w)

Scoring after treatment

24 hours

48 hours

6 days

female 301

10 + FCA

I

A

A

 

10

LI

I

I

 

5 + FCA

I

A

A

 

5

LI

I

I

female 302

10 + FCA

I

A

N

 

10

I

I

A

 

5 + FCA

I

A

A

 

5

LI

I

I

male 305

1 + FCA

I

I

A

 

1

LI

LI

LI

 

0.1 + FCA

I

I

I

 

0.1

LI

LI

LI

female 306

1 + FCA

I

I

A

 

1

LI

LI

LI

 

0.1 + FCA

I

I

I

 

0.1

LI

LI

LI

FCA : mixture Freund's Complete Adjuvant/0.9% NaCl (50/50, v/v)

N : necrosis

I : irritation

LI : slight irritation

A : crusts

Table 2: Range-finding test by topical application

Under the conditions of the induction phase

Animal

number

Concentration of the

test item % (w/w)

Scoring after removal of the dressing

24 hours

48 hours

female 303

50

3/A

3/A/Oe

female 304

25

3/A

LS/A/Oe

male 307

10

0

0

female 308

5

0

0

A : crusts

LS : scoring masked by dryness of the skin

Oe : oedema

Under the conditions of the challenge phase

Animal

number

Concentration of the

test item % (w/w)

 

Scoring after removal of the dressing

24 hours

48 hours

female 301

50

RF

2

2/S

25

LF

1

0

female 302

50

RF

2

2/S

25

LF

1

1

male 305

10

RF

0

0

5

LF

0

0

female 306

10

RF

0

0

5

LF

0

0

RF : right flank

LF : left flank

S : dryness of the skin

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

In a GLP skin sensitization test in guinea pigs, conducted according to OECD guideline 406, 2 out of 20 animals in Chimexane NV treated group and 1 animal in control group had positive reactions at both 24 and 48 h readings.


Migrated from Short description of key information:
In a GLP skin sensitization test in guinea pigs conducted according to OECD guideline 406, Chimexane NV elicited positive response in 2 out of 20 animals in test group at both 24 and 48 h readings.

Justification for selection of skin sensitisation endpoint:
Only one study available for this endpoint

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As less than 30% of total tested animals had positive response in a maximisation test, it is concluded that Chimexane NV does not need to be classified as skin sensitiser according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272 -2008).