Registration Dossier

Administrative data

Description of key information

Key study with guinea pig.

The test procedure was in accordance to OECD Guideline 406 (Skin Sensitisation) and was conducter under GLP conditions.

Result: no delayed contact hypersensitivity in guinea pigs was observed.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
In vivo (non LLNA). The study was conducted before the entry into force of REACH Regulation.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
and EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was conducted in 2002 before REACH Regulation (EC) 1907/2006 entered into force.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Source:Charles River Laboratories, Saint-Aubin-les-Elbeuf, France.
Sex:Male and female (nulliparous and non-pregnant)
Age/weight at study initiation:Age: 1 – 3 months old
Mean body weight males: 380 ± 31 g; females: 355 ± 13 g.
Route:
intradermal and epicutaneous
Vehicle:
other: 0.9 % NaCl
Concentration / amount:
Concentrations used for induction:0.031 % sodium chlorite (i.e. a 0.1 % solution of a 31 % solution of sodium chlorite)
Route:
epicutaneous, occlusive
Vehicle:
other: 0.9 % NaCl
Concentration / amount:
Concentrations used for challenge:0.31 % sodium chlorite (i.e. a 1 % solution of a 31 % solution of sodium chlorite)
No. of animals per dose:
10 animals/sex/group
Details on study design:
INDUCTION SCHEDULE:Intradermal route:Day 1: six injections were made into the dermis of a 4 cm x 2 cm clipped interscapular area using a needle (0.50 x 16 mm diameter). Three injections of 0.1 mL were made into each side of this interscapsular region.Cutaneous route:As the test item was shown to be irritant during the preliminary test, a topical application with sodium lauryl sulphate was not necessary on day 7.Day 8: a pad of filter paper (~8 cm2) was fully loaded with the test item at the concentration of 5% (w/w) (i.e. 1.55% sodium chlorite) and was then applied to the interscapular region of the animal of the treated group. The pad was held in place for 48 h.

CHALLENGE SCHEDULE
On day 22, the animals received an application of the test item and vehicle. The filter paper of a chamber (Finn Chamber®) was fully loaded with the test item at the concentration of 1% (w/w) (i.e. 0.31% sodium chlorite) and was then applied to the clipped area of the skin of the posterior right flank. The vehicle was applied to the posterior left flank. The chambers were held in contact with the skin for 24 h by means of an adhesive allergenic waterproof plaster.
Challenge controls:
5 animals/sex were used as control animals and were treated with water.
Positive control substance(s):
yes
Remarks:
Mercaptobenzothiazole (as a separate study)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No cutaneous reactions were observed.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No cutaneous reactions were observed.

Table A6_1_5-1.             Detailed information including induction/challenge/scoring schedule for skin sensitisation test

Guinea pig maximisation test (GPMT)

Inductions

GPMT

Observations/Remarks

 

day of treatment

application

 

Induction A

0

intradermal

 

Induction B

0

topical

 

challenge

22

topical

 

scoring 1

23

No reactions were observed

 

scoring 2

24

No reactions were observed

 

Table A6_1_5-2.         Result of skin sensitisation test

Number of animals with signs of allergic reactions /
number of animals in group

Negative control

Test group

Positive control

scored after 24h

0/10

0/10

10/10

scored after 48h

0/10

0/10

10/10

Interpretation of results:
GHS criteria not met
Remarks:
According to CLP criteria.
Conclusions:
No delayed contact hypersensitivity in guinea pigs was observed.
Executive summary:

The aim of the study was to determine the skin sensitisation in guinea pig due to the test material.

The test procedure was conducted according to OECD Guideline 406 (Skin Sensitisation) under GLP conditions.

Result: no delayed contact hypersensitivity in guinea pigs was observed.

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

Only one study available. Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data (no delayed contact hypersensitivity in guinea pigs was observed), the substance is not classified as skin sensitiser.