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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1999
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Information on test substance purity and identity is not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
EMPICRYL 6325
IUPAC Name:
EMPICRYL 6325
Constituent 2
Reference substance name:
Isotridecyl methacrylate
EC Number:
304-180-4
EC Name:
Isotridecyl methacrylate
IUPAC Name:
Isotridecyl methacrylate
Details on test material:
- Name of test material (as cited in study report): EMPICRYL 6325

According to a general product description of the supplier, EMPICRYL 6325 consists of Isotridecyl methacrylate with up to 5 % impurities.
Known impurities: methyl methacrylate, butyl methacrylate, isotridecyl alcohol

No specific information on purity of the test batch available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Induction: 25 % in arachis oil
Challenge: undiluted and 75 % in arachis oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Induction: 25 % in arachis oil
Challenge: undiluted and 75 % in arachis oil
No. of animals per dose:
20
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
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: undiluted. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 2.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75 % in arachis oil
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 % in arachis oil. No with. + reactions: 4.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75 % in arachis oil
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 % in arachis oil. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
other: 1st and 2nd reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 1st and 2nd reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of a Guniea pig maximisation study, the test substance EMPICRYL 6325, which contains Isotridecyl methacrylate, shows a skin
sensitisation potential. As there are data lacking on substance purity and identity and there is evidence for sensitising impurities (methyl methacrylate, butyl methacrylate), the relevance of the study is not assignable.
Executive summary:

In a Guinea Pig maximisation test according to OECD 406, the product EMPICRYL 6325 with the principal component isotridecyl methacrylate was tested.

Twenty test and ten control animals were used for the main study.

The concentrations of the test material for the induction and challenge phases were selected as follows:

Intradermal induction: 25 % in arachis oil

Topical induction: undiluted

Topical challenge: undiluted and 75 % in arachis oil

The test material produced a 35 % (7/20) sensitisation rate and was classified as a moderate sensitiser to guinea pig skin.

As there are data lacking on substance purity and identity and there is evidence for sensitising impurities (methyl methacrylate, butyl methacrylate), the relevance of the study is not assignable.

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