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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Skin sensititsation (OECD 406, Guinea Pig Maximisation Test): not sensitising

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07 Mar - 07 Apr 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
lack of individual test results and test material details. No data on reliablility check (positive control)
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 skin sensitisation study was available before REACH came into force, therefore no additional LLNA test was performed.
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
Route:
intradermal and epicutaneous
Vehicle:
other: Paraffin perliquid DAB 8
Concentration / amount:
Intradermal induction: 0.1%
Epicutaneous induction: 15%
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
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Paraffin perliquid DAB 8
Concentration / amount:
2.5% on one flank, 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 10 and 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 of both applied concentrations (2.5 and 5%)
- Concentrations: 2.5 and 5%
- Evaluation (hr after challenge): 24 and 48 h
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
intradermal induction: 0%; challenge: 2.5 and 5% (parallel application)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
intradermal induction: 0.1%; challenge: 2.5 and 5% (parallel application)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
intradermal induction: 0%; challenge: 2.5 and 5% (parallel application)
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight redness of the skin
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
intradermal induction: 0.1%; challenge: 2.5 and 5% (parallel application)
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested

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 treated 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.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Sensitisation

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

 

CAS 29059-24-3

20 female Pirbright white guinea pigs were induced with a single intradermal injection of the test substance at 0.1% in Paraffin perliquid DAB 8 and with an epicutaneous occlusive application of the test substance at 15% on the shoulder region 7 days later (Henkel, 1989). A negative control group of 20 animals was treated with Paraffin perliquid DAB 8 only. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions at test substance concentrations of 2.5% and 5%, respectively. All test and control animals showed no skin reactions after 24 and 48 h with one exception only. In one control animal, a slight redness of the skin after 48 h was apparent. No positive control data was included in the study report for reliability check.

In summary, based on the available data on the skin sensitisation properties of the category members, it is concluded, that there is no evidence of sensitising properties of Myristic acid, monoester with propane-1,2-diol.

 

Conclusion on skin sensitising properties

The available data point to non-sensitising properties of the read-across analogue. Thus, Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) is not considered as skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.