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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study in full compliance with OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Skin sensitization study using guinea pig maximisation test following OECD guideline 406 was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-Diaminotoluene, propoxylated
EC Number:
918-139-9
Cas Number:
1228577-90-9
Molecular formula:
(C3H6O)n (C3H6O)n (C3H6O)n (C3H6O)n C7H10N2 sum of n: >1 - <8.5
IUPAC Name:
1,2-Diaminotoluene, propoxylated
Details on test material:
- Name of test material (as cited in study report): NLP#10, Tercarol 5903
- Physical state: liquid, strong viscous
- Analytical purity: content 100%
- Impurities (identity and concentrations):
- Molecular weight: Mn = 340 g/mole

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl: HA
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: polyethylene glycol 400; formulations were heated up in a water bath (40°C) for approximately 30 minutes
Concentration / amount:
5% for intradermal induction
50% for topical induction
50% for first challenge
25% for second challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: polyethylene glycol 400; formulations were heated up in a water bath (40°C) for approximately 30 minutes
Concentration / amount:
5% for intradermal induction
50% for topical induction
50% for first challenge
25% for second challenge
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:
- for intradermal induction: concentrations of 0, 1, 2.5, and 5 % were tested
- for topical induction: concentrations of 0, 12, 25, and 50 % were tested
- for challenge: concentrations of 0, 12, 25, and 50 % were tested
Application of 100% was not possible because of the high vicosity of the test material.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2; first induction intradermal, second induction topical 7 days later
- Exposure period: 48 h occusive in the topical induction
- Test groups: 10 animals
- Control group: 5 animals
- Concentrations: 5 % for intradermal induction, 50 % for topical induction

B. CHALLENGE EXPOSURE
- No. of exposures: 2, first challenge topical and second challenge topical
- Day(s) of challenge: first challenge started 3 weeks after intradermal induction, second challenge 7 days later
- Exposure period: 24 hours semiocclusive for each challenge
- Concentrations: 50 % for first challenge, 25 % for second challenge
- Evaluation (hr after challenge): 48 and 72 hours after start of challenge

Reliability of the test system is routinely confirmed by alpha hexyl cinnamic aldehyde.
Challenge controls:
yes: control group animals were treated in challenge experiments according to test group animals
Positive control substance(s):
not required

Results and discussion

Positive control results:
Routinely performed tests with positive controls confirmed the reliability of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
Positive control was not tested.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

The first challenge with the 50% test item formulation led to skin effects (grade 1) in 5 of 10 animals of the test item group (50%) and in 3 of 5 animals (grade 1) of the control group (60%). The second challenge with the 25% test item formulation led to no skin effects in the animals of the test item group and the control group. In summary, under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits no skin-sensitization potential.

Applicant's summary and conclusion

Conclusions:
not sensitising
Executive summary:

NLP#10 (ortho-toluene diamine, propoxylated) was tested in the Guinea Pig Maximization Test (GPMT) on 15 female test animals (10 for the test item group, 5 control animals) for its skin sensitizing properties (OECD 406). Concentrations of 5% (intradermal induction), 50% (topical induction and first challenge) and 25% (second challenge) of the test material in PEG 400 were used. Under the conditions of the test NLP#10 was shown to exhibit no skin sensitization potential.