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Description of key information

Non sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Induced hypersensitive response of experimental animals to allergen challenge. Skin sensitization is immune skin reactions in guinea pigs is reflected blood flow, swelling.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
Species:
guinea pig
Sex:
female
Details on test animals and environmental conditions:
- Numbero of animals: 20
- Non pregnant
- Weight: 250-350 g
- Diet: KO 16 ad libitum
- Water: drinking water with ascorbic acid
- Cage: T5 (supplied by Velaz)
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal:
0,1 mL at 25 %;
0,1 mL at 5 % of dye
0,1 mL at 5% of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal:
0.1 mL at 25 %
0.1 mL at 5 % of dye
0.1 mL at 5 % of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
No. of animals per dose:
2
Details on study design:
- Route of application: injection and patch application
- Exposure period: 72 hours
- Post-exposure period of observation: 14 days
Positive control substance(s):
yes
Reading:
1st reading
Hours after challenge:
1
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0,1
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
weak swelling; edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: not reported
Interpretation of results:
GHS criteria not met
Conclusions:
Non sensitising
Executive summary:

Method

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Results

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Conclusion

Non sensitising.

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

To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.

Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

SKIN SENSITIZATION

Category 1

According CLP Regulation N. 1272/2008, a substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).

At this point, when an adjuvant type guinea pig test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant guinea pig test method a response of at least 15 % of the animals is considered positive.

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay-EC3 value ≤ 2 %

Guinea pig maximisation test-≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Local lymph node assay - EC3 value > 2 %

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.

The tested substance has not to be classified as skin sensitiser because the highest positive reaction value of the test is 15 % responding at 5 % intradermal induction dose.

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