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Diss Factsheets

Toxicological information

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented pubblication with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Allergenicity of Aminobenzene compounds: structurefunction relationships
Author:
Kleniewska D and Maibach H
Year:
1980
Bibliographic source:
Beruf Umwelt 28: 11-13.
Reference Type:
secondary source
Title:
p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
Author:
OECD
Year:
2005
Bibliographic source:
UNEP Publications

Materials and methods

Principles of method if other than guideline:
Patch test was performed with 10 guinea pigs using a 2 % p-toluidine petrolatum solution and occlusive dressing for induction. 14 days later, 4 concentrations for the challenge procedure were used: 2 %, 1 %, 0.5 %, 0.25 %. p-Toluidine was evaluated as sensitizing because 8/10 guinea pigs showed a positive reaction in the highest concentration (2 %). 6/10, 4/10 and 0/10 animals showed a positive reaction after challenge with 1, 0.5 or 0.25% p-toluidine. As positive control served p-phenylene diamine.

GLP compliance:
no
Remarks:
GLP compliace was not madatory at the time of the study
Type of study:
patch test

Test material

Constituent 1
Chemical structure
Reference substance name:
p-toluidine
EC Number:
203-403-1
EC Name:
p-toluidine
Cas Number:
106-49-0
Molecular formula:
C7H9N
IUPAC Name:
4-methylaniline
Details on test material:
- Name of test material (as cited in study report): p-toluidyne
- Analytical purity: no data
- Other: p-toluidine, purified by recrystalisation

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: the animals were obtained from a commercial supplier
- Weight at study initiation: 300-400 g
- Diet (e.g. ad libitum): standard guinea pig chow ad libitum, and lettuce weekly
- Water (e.g. ad libitum): ad libitum

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Induction of sensitization: 2%
Challenge: 2%, 1%, 0.5%, 0.25%
Challengeopen allclose all
Route:
other: Closed technique: Finn chamber (Epitest), secured with plastic tape and rubber dressing
Vehicle:
petrolatum
Concentration / amount:
Induction of sensitization: 2%
Challenge: 2%, 1%, 0.5%, 0.25%
No. of animals per dose:
10
Details on study design:
10 albino Hartley strain guinea pigs were used per challenge dose
Application area: flank over the scapula was clipped and shaved
Induction: 2 % in petrolatum, four times for 24 hours each, occlusive patches (plastic tape) on alternate days secured with a rubber dressing wound around the trunk
Challenge: 14 days after exposure, the animals were challenged with 4 concentrations on the opposite flank (2%, 1%, 0.5%, 0.25%) with a closed technique: Finn chamber, secured with plastic tape and rubber dressing.
Readings: 24, 48, and 72 hours after removal; maximum responses were at 48 hours
The reaction intensity was evaluated according to the following 4 point scale
0=no visible reaction
1=slight erythema
2=moderate erythema
3=intense erythema and swelling

Statistical method: Analysis of variance


Positive control substance(s):
yes
Remarks:
Paraphenylenediamine

Results and discussion

Positive control results:
see Table 1 in Remarks on results including tables and figures

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours
Hours after challenge:
72
Group:
test chemical
Dose level:
2%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours. . Hours after challenge: 72.0. Group: test group. Dose level: 2%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours
Hours after challenge:
72
Group:
test chemical
Dose level:
1%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
other: Reading: other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Reading:
other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Reading: other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5%. No with. + reactions: 4.0. Total no. in groups: 10.0.
Reading:
other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours
Hours after challenge:
72
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: readings were performed 24, 48, and 72 hours after removal. Maximum responses were at 48 hours. . Hours after challenge: 72.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Table 1: Challenge concentrations and number of responding animals after treatment with p-toluidine and p-phenylene-diamine, respectively

Challenge concentration p-toluidine (%)

No. of animals responding 

Meanscore 

Challenge concentration p-phenylene-diamine (%)

No. of animals responding

Mean score 

 2

 8/10

 1.4±0.8

 

2 

10/10 

2.2 ±0.6

 1

 6/10

 0.8±0.7

1 

10/10 

2.1 ±0.5

 0.5

 4/10

 0.4±0.5

0.5 

10/10 

1.5 ±0.5

 0.25

 0/10

 0

0.25 

4/10 

0.5 ± 0.5

 

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information p-Toluidine is a sensitizer by skin contact as shown in a patch test with guinea pigs.
Executive summary:

Kleniewska & Maibach (1980)

 

Patch test was performed with 10 guinea pigs using a 2 % p-toluidine petrolatum solution and occlusive dressing for induction. 14 days later, 4 concentrations for the challenge procedure were used: 2 %, 1 %, 0.5 %, 0.25 %. p-Toluidine was evaluated as sensitizing because 8/10 guinea pigs showed a positive reaction in the highest concentration (2 %). 6/10, 4/10 and 0/10 animals showed a positive reaction after challenge with 1, 0.5 or 0.25% p-toluidine. As positive control served p-phenylene diamine.

On the basis of this finding p-toluidine can be classified as R43 (may cause sensitization by skin contact) according to the EU and Skin Sens.1, H317, may cause allergic skin reaction