Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted using a modified Landsteiner technique. A positive control substance was included in this study. There were 6 animals in the positive control group and 9 animals in the test group.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A modified Landsteiner technique (Landsteiner, K., and Jacob, J., Exptl. Med. 61, 643, 1935; Draize, J.H., Woodard, G., and Calvery, H.O., J. Pharmacol. Exptl. Therap. 82, 337, 1944) was used to evaluate the possibility of skin sensitization from the test substance.
GLP compliance:
no
Type of study:
other: modified Landsteiner technique

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-xylenol
- Physical state: white solid
- Analytical purity: The material was considered to be free of impurities.
- Other: received on February 25, 1965. The test substance has a strong pungent odor.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 310 to 709 grams
- Housing: The animals were housed by groups in metal cages.
- Diet: Purina Rabbit Chow were available at all times and fresh lettuce was supplied once daily
- Water: Water was available at all time.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: ethyl alcohol
Concentration / amount:
0.1% weight/volume in vehicle (70% ethyl alcohol).
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: ethyl alcohol
Concentration / amount:
0.1% weight/volume in vehicle (70% ethyl alcohol).
No. of animals per dose:
The positive control group consisted of 6 animals, and the test group consisted of 9 animals.
Challenge controls:
A challenge of freshly prepared control was administered in the same manner as the sensitizing doses.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene(DNCB)

Results and discussion

Positive control results:
The first or three sensitizing doses of 1-chloro-2,4-dinitrobenzene produced no signs of irritation, while the remaining seven or eight doses generally elicited moderate erythema; slight edema was noted following four to seven of the doses and blanching at the center of the site was noted following three to eight of the doses.
The challenge dose of the positive control material produced a skin response either slightly more intense or essentially the same as that produced by the latter sensitizing doses. In two of the animals the diameter of the area involved was considerably greater than the average of the sensitizing doses, and in two additional animals the intensity and area were both greater, indicating possible sensitization in four of the six animals.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1% weight/volume in vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
All animals seemed normal in appearance and behavior and gained weight.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% weight/volume in vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: All animals seemed normal in appearance and behavior and gained weight..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1% weight/volume in vehicle
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
All animals seemed normal in appearance and behavior and gained weight.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% weight/volume in vehicle. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: All animals seemed normal in appearance and behavior and gained weight..
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5% weight/volume in vehicle
No. with + reactions:
4
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5% weight/volume in vehicle. No with. + reactions: 4.0. Total no. in groups: 6.0.

Any other information on results incl. tables

All animals seemed normal in appearance and behavior and gained weight.

No signs of irritation were noted following any of the sensitizing doses in two of the test animals. In the remaining animals of the test group, slight erythema was noted following one to four of the sensitizing doses. No response was noted in the test animals after the challenge, indicating absence of sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance did not produce sensitization in guinea pigs by modified Landsteiner technique based on the results of this study. A known sensitizer, 1-chloro-2,4-dinitrobenzene produced apparent sensitization in four of the six guinea pigs in this study.