Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Endpoint summary

Currently viewing:

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
Study period:
16-Feb-1993 to 14-Feb-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In 1994, the LLNA was not validated.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre d'élevage Lebeau, 78950 Gambais, France
- Age at study initiation: no data
- Weight at study initiation: 442 +/- 29 g for males and 417 +/- 25g for females
- Housing: individually in polycarbonate cage
- Diet (ad libitum): Guinea-pigs sustenance reference 106 diet, UAR, France
- Water (ad libitum): filetred tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction (treated group)
· intradermal injections (day 1): 25 % IOTG in paraffin oil,
· topical application (day 8): undiluted IOTG
Challenge (all groups)
· topical application (day 22): undiluted IOTG.
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction (treated group)
· intradermal injections (day 1): 25 % IOTG in paraffin oil,
· topical application (day 8): undiluted IOTG
Challenge (all groups)
· topical application (day 22): undiluted IOTG.
No. of animals per dose:
5 (control) or 10 (test substance)
Details on study design:
1st application: Induction 25 % intracutaneous
2nd application: Induction undiluted occlusive epicutaneous
3rd application: Challenge undiluted occlusive epicutaneous
Positive control substance(s):
yes
Remarks:
Dinitro-2,4-chlobenzene
Positive control results:
Dinitro-2,4-chlorobenzene (0.5%) induced positive skin sensitization reactions in 100% (5/5) of the guinea pigs.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml 100% iOTG
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No oedema was noted. In the treated group, a positive response characterised by a well-defined erythema was observed on the right flank (test substance) of 3 and 5 treated animals after 24 and 48 hours, respectively.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 ml 100% IOTG
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 ml 100% IOTG. No with. + reactions: 1.0. Total no. in groups: 9.0.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 ml 100% iOTG
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 ml 100% iOTG. No with. + reactions: 0.0. Total no. in groups: 9.0.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 ml 100% iOTG
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
Hours after challenge: 24.0. Group: test group. Dose level: 0.5 ml 100% IOTG. No with. + reactions: 3.0. Total no. in groups: 20.0.
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 ml 100% iOTG
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Hours after challenge: 48.0. Group: test group. Dose level: 0.5 ml 100% iOTG. No with. + reactions: 5.0. Total no. in groups: 20.0.
Remarks on result:
positive indication of skin sensitisation

After the challenge application of the test substance,
slight cutaneous reactions attributed to a slight irritant
potential of the test substance were observed in one animal
of the control group and in 4 animals of the treated group.
A positive response characterised by a well-defined erythema
was observed on the right flank (test substance) of 3 and 5
treated animals after 24 and 48 hours, respectively.
No oedema was noted.
A dryness of the skin was noted after 48 hours in 5/20
animals of the treated group.
The well-defined cutaneous reactions observed were
attributed to a hypersensiting effect of the test substance
on 5/20 animals (25%).

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Under our experimental conditions and according to the maximization method established by Magnusson and Kligman, cutaneous reactions attributable to the sensitization potential of the test substance iOTG in its original form were observed in 5/20 (25%) guinea-pigs. The allergenicity level is II (weak).
Executive summary:

During the study, no clinical signs or deaths related to the treatment were observed. The body weight gain of the animals of the treated group was normal when compared to that of the animals of the control group. After the challenge application of the test substance, slight cutaneous reactions attributed to a slight irritant potential of the test substance were observed in one animal of the control group and in 4 animals of the treated group. A positive response characterised by a well-defined erythema was observed on the right flank (test substance) of 3 and 5 treated animals after 24 and 48 hours, respectively. No oedema was noted.

A dryness of the skin was noted after 48 hours in 5/20 animals of the treated group. The well-defined cutaneous reactions observed were attributed to a hypersensiting effect of the test substance in 5/20 animals (25%). 



Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to REGULATION (EC) No 1272/2008 of 16 December 2008 and the available skin sensitization data, iOTG should be classified as skin sensitiser (category 1B).