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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
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.
Route:
epicutaneous, open
Vehicle:
other: ethyl alcohol
Concentration / amount:
0.1% weight/volume in vehicle (70% ethyl alcohol).
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)
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.
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.

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.

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

A study was conducted to assess the potential of the test material to cause sensitisation to the albino guinea pig using a modified Landsteiner technique. The study was awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).

Nine albino guinea pigs were exposed to the test material via the epicutaneous route (open) at a dose level of 0.1 % weight/volume in vehicle (70 % ethyl alcohol).The sensitizing doses and the challenge dose were administered by topical application of one drop (about 0.05 mL) to an abraded area on the back or flank. The drop of solution was then rubbed gently on the abraded site. The sensitizing doses were made at random over an area of the flank, two or three times weekly for a total of ten applications.

Thirteen days after the last sensitizing dose, a challenge dose of freshly prepared control and test solution was administered in the same manner as the sensitizing doses. The application sites were examined for signs of irritation at 24 and 48 hours following each exposure. Skin responses were evaluated according to degree of erythema and edema produced and diameter of area involved.

Body weights were recorded at weekly intervals. The study was terminated 48 hours after challenge dose was administered.

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

A known sensitizer, 1-chloro-2,4-dinitrobenzene produced apparent sensitization in four of the six guinea pigs in this study.

Under the conditions of this study, the test material did not produce sensitization in guinea pigs.


Migrated from Short description of key information:
The test material was determined not to be sensitising to the albino guinea pig using a modified Landsteiner technique.

Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to skin sensitisation.