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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
Study period:
November 28, 1978 to January 6, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was performed prior to the implementation of Good Laboratory Practice standards. No test guideline was available at the time this study was performed; however, the data are documented sufficiently to allow for a critical assessment of the endpoints evaluated.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Animals were administered the test material via the intracutaneous route. A total of ten injections were administered every other day and the application sites were evaluated 24 hours after each dose. Two weeks after the tenth injection, a challenge injection was administered. Readings were made 24 and 48 hours after the challenge injection.
GLP compliance:
no
Type of study:
intracutaneous test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No information was provided in the test report other than a statement that the test material was DETDA.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
A group of 10 guinea pigs weighing between 300 and 400 grams was employed in the study. No information was provided on the supplier or environmental conditions.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
1st injection = 0.5 mL; 2nd-9th injections = 0.1 mL; challenge injection = 0.05 mL
Challengeopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
1st injection = 0.5 mL; 2nd-9th injections = 0.1 mL; challenge injection = 0.05 mL
No. of animals per dose:
6 treated with DETDA, 4 positive controls
Details on study design:
The backs of ten guinea pigs were clipped free of hair. Six guinea pigs were treated with DETDA. This study was performed by the intracutaneous route, using a 26 gauge-1/2" hypodermic needle. The injections were made every other day or three times weekly, until a total of ten injections had been made. The ten sensitizing injections were made at sites selected at random in an area (approximately 3-4 cm^2) on the back and upper flanks. The re-test injection was made in an area just below the sites of the sensitizing injections. The first injections consisted of 0.05 mL, while the remaining nine injections consisted of 0.1 mL each. Ten weeks after the tenth injection, a re-test or challenge injection was made using 0.05 mL. Readings were made 24 and 48 hours after the challenge injection.
Challenge controls:
4 guinea pigs served as positive controls.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene solution in ethylene dichloride

Study design: in vivo (LLNA)

Vehicle:
other: Not applicable
Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
Not applicable

Results and discussion

Positive control results:
Four guinea pigs were treated as described above under "Details of Study Design" with 0.1% dinitrochlorobenzene solution in ethylene dichloride. This group served as a positive control. The positive control proved to be a sensitizing agent.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1 mL
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 mL. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 mL
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 mL. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1%
No. with + reactions:
4
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
4
Total no. in group:
4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 4.0. Total no. in groups: 4.0.

Applicant's summary and conclusion

Conclusions:
From the results obtained in this study, it appears that DETDA is a primary skin irritant and fatiquing agent in guinea pigs. It does not appear to be a sensitizing agent.