Registration Dossier

Administrative data

Description of key information

Signs of corrosive effects were observed in a skin irritation study in one New-Zealand white rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Housing temperature and area of application not reported.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Housing temperature and area of application not reported.
Principles of method if other than guideline:
Not applicable
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: After 3 min exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24 h, 48 h, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: After 3 min exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24 h, 48 h, 72 h
Score:
2.3
Max. score:
4
Reversibility:
no data
Remarks on result:
other: After 4 h exposure
Other effects:
A yellow coloration of the skin also observed at the 24 h and 48 h readings after both exposures.

Table 1: 3-minute exposure - Cutaneous examinations and mean values of the scores

Dermal irritation

Scores

Mean irritation score

 

1 h

24 h

48 h

72 h

 

erythema

0

0

0

2

0.7

oedema

0

0

0

3

1.0

other

none

Yellow coloration

Yellow

coloration

none

 

Table 2: irritation scores for the 14-day observation period after 3-min exposure

Dermal irritation

Scores 

 

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

erythema

2

2

2

1

1

1

1

1

1

0

oedema

2

2

2

0

0

0

0

0

0

0

other

none

none

Dryness of the skin

 

Dryness of the skin

Dryness of the skin

Dryness of the skin

none

none

none

none

Table 3: 4-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal

Dermal irritation

Scores

Mean irritation score

 

1 h

24 h

48 h

72 h

 

erythema

1

1

2

Scoringmasked by necrosis

(2) (not calculated)

oedema

0

0

3

4

2.3

other

none

Yellow coloration

Yellow

coloration

none

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a GLP study conducted according to OECD guideline 404, a New-Zealand white rabbit treated with 0.5 mL of Chimexane NV for 4 h showed necrosis associated with a severe oedema on the whole treatment site on Day 4.

According to ANNEX VII column 2 of the REACH regulation, no study was needed to assess eye irritation as Chimexane NV is classified as corrosive.

When taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.


Justification for selection of skin irritation / corrosion endpoint:
Only one study assessing the irritant potential of the substance.

Justification for selection of eye irritation endpoint:
One skin irritation study showing corrosive effects on skin is available. A waiver is therefore submitted for this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

As corrosive effects were observed on the skin of a New-Zealand white rabbit exposed by dermal route to Chimexane NV for 4 h, Chimexane NV is classified as corrosive (C; R34) according to the Directive 67/548/EC and category 1C according to CLP Regulation (EC) N° (1272-2008).

No study for eye irritation was performed; when taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.