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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No guideline but according to Magnusson & Kligman
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
according to Magnusson,S. and Kligman,J. Maximisation test. J. Invest. Derm. 52, 268 - 276 (1969) and Contact Dermatitis 6, 46 - 50, (1980)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
At beginning the guinea pigs were 10 weeks old (267 - 400 gm, body weight) . They were housed individually in Macrolon cages (type3) , and individually identified with ear tags. They were kept at constant room temperature (21 +/- 2°C) and a humidity of 50 +/- 10%, and on a 12 hour dark/light cycle. All animals received diet and water ad libitum.
The sensitivity of the strain was tested every 6 months with p-phenylendiamine

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: acetone
Concentration / amount:
10% in acetone
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone
Concentration / amount:
10% in acetone
No. of animals per dose:
10 males and 10 females per group
Details on study design:
First induction with 0.1 ml Freund's adjuvant intradermally, and test substasnce epidermally directly on the injection site with occlusive dressing (24 hours).
Second induction week test substance epidermally applied with occlusive dressing (application sites pretreated with 10% lauryl sulfate as an open application)
Challenge: 14 days later substance applied on filter paper to the shaved flank with occlusive dressing for 24 hours.
24 and 48 hours later the skin reactions were scored
A control group received the same treatment but with out test substance.
Challenge controls:
The maximum sub-irritant concentration was used for the challenge reactions.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
no statistics was applied

Results and discussion

Positive control results:
performed every 6 months to prove the sensitivity of the guinea pig strain . no data in the report

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of toxicity.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
erythema and oedema reactions
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. Clinical observations: erythema and oedema reactions.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
erythema and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20).
The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling
Executive summary:

Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20). The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling