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Diss Factsheets

Toxicological information

Skin sensitisation

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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:
weight of evidence
Study period:
07 Mar - 07 Apr 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Basic data given (comparable to guideline study). Lack of individual test results and test material details. No data on reliablility check (positive control)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of individual test results and test material details. No data on reliability check (positive control)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid GPMT test was available before REACh came into force, therefore no new LLNA test was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Myristic acid, monoester with propane-1,2-diol
EC Number:
249-395-3
EC Name:
Myristic acid, monoester with propane-1,2-diol
Cas Number:
29059-24-3
Molecular formula:
C17H34O3
IUPAC Name:
2-hydroxypropyl myristate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann, Borchen, Germany
- Weight at study initiation: 352.6 g (control group, range finding study) and 349.4 g (treatment group, range finding study); 298.5 g (control group, main study) and 298.4 g (treatment group, main study)
- Housing: animals were housed in groups of 2-3 in Makrolon IV cages
- Diet: Altromin-Haltungsdiät 3032 DK (Fa. Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Paraffin perliquid DAB 8
Concentration / amount:
Induction: 0.1% (intradermal), 15% (epicutaneous)
Day(s)/duration:
intradermal induction: single treatment; epicutaneous induction: 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Paraffin perliquid DAB 8
Concentration / amount:
Challenge: 2.5 % on one flank and 5% on the other flank
Day(s)/duration:
24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
2 x 3 (range finding study)
20 (main study)
Details on study design:
RANGE FINDING TESTS:
Test group A:
To evaluate the concentration for intracutaneous induction 3 guinea pigs were tested with 0.1, 0.5, 1.0 and 2.0% (intracutaneous) of the test substance. The 0.1% concentration of the intracutaneous application caused a sufficient irritation on the skin. Therefore, a 0.1% concentration was chosen for intracutaneous induction exposure.
Test group B:
To evaluate the epicutaneous induction and the challenge concentration, 3 guinea pigs were tested with 5, 10 and 15% (epicutaneous) with the test substance. Due to the only slight skin reactions at 15%, this concentration was chosen for epicutaneous induction and 2.5 and 5% as challenge concentration.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: the test substance in Paraffin perliquid DAB 8
Injection 3: the test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in Paraffin perliquid DAB 8

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: Paraffin perliquid DAB 8
Injection 3: Paraffin perliquid DAB 8 in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in Paraffin perliquid DAB 8

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 0.1%, epicutaneous 15%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: parallel application onto the flank
- Concentrations: 2.5 and 5%
- Evaluation (hr after challenge): 24 and 48 h

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Group:
positive control
Remarks on result:
other: No information available
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight redness of the skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight redness of the skin.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

No mortality was observed in any control or treatment animal.

The individual body weights of the control and test animals showed the expected values.

After intracutaneous induction all animals showed the characteristic reactions after application of FCA (Freund´s complete adjuvant). The test substance without FCA caused moderate skin reactions which were of a lower grade than the reactions caused by FCA alone or by the solution of FCA with the test substance.

After patch removal after the second induction (epicutaneous induction) bloody skin alterations were observed. Later on, this skin reactions changed to necrotic and escharic skin reactions.

24 and 48 h after patch removal (challenge induction) no skin reaction was observed in the treatment animals. In 1 control animal (animal No. 16; 48 h reading) a slight reaction was apparent. According to the author, the results were therefore not presented in table form.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.