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Diss Factsheets

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
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Magnusson Kligman Maximization Test
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction: 10% v/v DMTDA in paraffin oil

10% v/v DMTDA in Freuds complete adjuvant
(FCA)

second induction: DMTDA as supplied

Concentration of test material and vehicle used for each challenge:

First challenge: 50% v/v DMTDA in paraffin oil

10% v/v in paraffin oil

2nd challenge: 5 % v/v in paraffin oil

1% v/v in paraffin oil
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
First induction: 10% v/v DMTDA in paraffin oil

10% v/v DMTDA in Freuds complete adjuvant
(FCA)

second induction: DMTDA as supplied

Concentration of test material and vehicle used for each challenge:

First challenge: 50% v/v DMTDA in paraffin oil

10% v/v in paraffin oil

2nd challenge: 5 % v/v in paraffin oil

1% v/v in paraffin oil
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
3
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
5 %
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
5
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 5.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Signs of irritation during injection:

Intradermal injections of FCA caused moderate erythema.

Similar injections of 10% v/v DMTDA in paraffin oil or FCA caused slight or moderate erythema. Injection of paraffin oil caused no reaction.

Evidence of sensitisation of each challenge concentration:

Slight erythema or a more marked response (Grade 1 or above). DMTDA caused an irritation in control animals in 1st challenge.

Other observations:

Erythema observed in control group, less marked at lower concentrations, indicating a primary irritant effect not observed for rabbit (Test 4.1.5 above).

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be a skin sensitizer under the conditions of this maximization test on guinea pigs.
Executive summary:

The potential of the test article to cause delayed contact hypersensitivity in guinea pigs was assessed by the Magnusson Kligman Maximization test according to OECD 406 and EU method B.6. 20 animals were used for test group and negative control group each. The shaven dorsa of 10 female and 10 male Dunkin-Hartley guinea pigs were subject to intradermal injections of FCA, 10 % v/v test article in paraffin oil and 10 % v/v test article in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of test article as supplied and the test site was covered by an occlusive dressing for 48 hrs. On day 22, all animals were challenged by occluded application of paraffin oil to the left flank and 50 % and 10 % v/v test article in paraffin oil to two sites on the right flank. The occlusive dressings were removed on the following day and the condition of the test sites was assessed approximately 24 and 48 hrs later. The challenge application of test article in paraffin oil caused significant erythema as follows: 4/20 vs 8/20 and 2/20 vs 6/20 in 50 % and 10 % groups (controls vs experimental) respectively 1/20 vs 7/20 and 0/20 vs 6/20 in the 50 % and 10 % groups (control vs experimental) respectively.

Results of test difficult to interpret due to primary irritation in the control animals. However overall the test was considered to give a positive result ie the substance is classified as a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Results of test difficult to interpret due to primary irritation in the control animals. However overall the test was considered to give a positive result ie the substance is classified as a skin sensitiser.



Migrated from Short description of key information:
Conclusion: test substance causes skin sensitization

Justification for selection of skin sensitisation endpoint:
available study

Justification for classification or non-classification