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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
09 Mar - 30 Apr 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no rationale for used concentrations given, limited etails on test substance purity).

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:
yes
Remarks:
analytical purity of test substance not specified, no range finding for irritation, thus no explanation for used concentrations of 5% for intra- and epidermal induction, 25% for challenge
Principles of method if other than guideline:
Magnusson and Kligman method in guinea pigs
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl myristate
EC Number:
203-751-4
EC Name:
Isopropyl myristate
Cas Number:
110-27-0
Molecular formula:
C17H34O2
IUPAC Name:
isopropyl myristate
Details on test material:
- Name of test material (as cited in study report): Isopropylmyristate
- Analytical purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Züchter Winkelmann, Borchen
- Weight at study initiation: test group mean: 382 g; control group mean: 337 g
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50 - 56
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Carboxymethylcellulose, Cremophor
Concentration / amount:
5% for injection
5% for dermal induction
25% for dermal challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Carboxymethylcellulose, Cremophor
Concentration / amount:
5% for injection
5% for dermal induction
25% for dermal challenge
No. of animals per dose:
15 for treatment, 19 as control
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: injection on day 1, epidermal application on day 7
- Test groups: 3 injections: 0.1 mL Freund's adjuvant, 0.1 mL 5% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor, 0.1 mL Freund's adjuvant with test substance 1:1, concentration 5%; epidermal application: 5% in Vaseline
- Control group: the same than test group without test substance
- Site: two rows with 3 injections right and left of the scapular midline, dermal application on the injections sites
- Frequency of applications: 1
- Duration: single injections and 48 h dermal exposure under occlusive conditions
- Concentrations: 5%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after dermal induction (day 22)
- Exposure period: 24 h
- Test groups: 0.1 mL 25% test substance in 2% Carboxymethylcellulose and 0.5% Cremophor
- Control group: 0.1 mL 2% Carboxymethylcellulose and 0.5% Cremophor
- Site: test substance on the right flank, vehicle on the left
- Concentrations: 25% and vehicle only
- Evaluation (hr after challenge): 48 and 72 h

Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: none.

Any other information on results incl. tables

The test substance is not sensitising to the skin of guinea pigs, when used as 5% solution for induction and 25% solution for challenge.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified