Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: small number of animals tested; reactions should have been scored additionally at 48 hours
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
The equivalent total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the Injection Challenge Concentration (ICC)
Principles of method if other than guideline:
Method: other: see freetext ME
GLP compliance:
not specified
Type of study:
Draize test
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 350 g
- Housing: 2/per cage, same sex
- Diet ad libitum
- Water ad libitum
- Acclimation period:


Route:
intradermal
Vehicle:
no data
Concentration / amount:
induction concentration: 0.1%
Challenge concentration 10 %
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
induction concentration: 0.1%
Challenge concentration 10 %
No. of animals per dose:
10
Details on study design:
10 guinea pigs (4 males and 6 females or vice versa). Both flanks of each  guinea 
pig were shaved, intradermal injections or topical applications  were performed 
without occlusion. Primary irritation tests were performed to determine the suitable  concentrations.

METHOD: Each animal was injected intradermally with 0.1 ml of TS at 2.5 times the 
determined injection challenge concentration (ICC) of 0.1 %  at 4 sites  
which overlie the 2 auxilliary and the 2 inguinal lymph nodes. 14 days  later 
each animal was challenged intradermally in one flank and topically  in the
 other with 0.1 ml aliquots of TS at the respective ICC and  application 
challenge concentration (ACC; 10%). 24 hours later the  reactions were scored. 

To confirm the result, the procedure was repeated  including a confirmatory 
challenge with controls.

1st application: Induction 0.1 % intracutaneous
2nd application: Challenge 10 % intracutaneous
3rd application: Challenge 10 % other: topical application
Challenge controls:
At each challenge with controls 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and
topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively
Positive control substance(s):
not specified
Positive control results:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
other: no details given
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: no details given. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

p-cresol did not reveal sensitizing potency in a modified Draize test with guinea pigs.

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

p-cresol did not reveal sensitizing potency in a modified Draize test with guinea pig (Sharp 1978). In addition, p-cresol was evaluated as being non-sensitizing following a maximization test in human volunteers (Opdyke 1974).


Migrated from Short description of key information:
p-cresol did not reveal sensitizing potency in a modified Draize test with guinea pig (Sharp 1978). In addition, p-cresol was evaluated as being non-sensitizing following a maximization test in human volunteers (Opdyke 1974).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data , no classification and labelling is required.