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Description of key information

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:
March-May 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been conducted according to OECD guideline No. 406 and under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Himalayan
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ibm, GOHI, SPF-quality guinea pigs (males)
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 388-447 g
- Housing: individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): pelled standard guinea pig breeding/maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water ad libitum
- Acclimation period: one week for the control and test group under test condition after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From 11 March 2002 to 18 April 2002
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
A 5% dilution of the test item in PEG 300 was used for the intradermal induction. The epidermal induction of sensitization was conducted with the undiluted test item. Animals were challenged by epidermal application with a 5% dilution of the test item in PEG 300.
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
A 5% dilution of the test item in PEG 300 was used for the intradermal induction. The epidermal induction of sensitization was conducted with the undiluted test item. Animals were challenged by epidermal application with a 5% dilution of the test item in PEG 300.
No. of animals per dose:
5 males were used in the pre-test. 15 males in the main study: 5 in the control group and 10 in the test group.
Details on study design:
RANGE FINDING TESTS:
Based on the results obtained ib the pre-test, the concentration selected for induction and challenge in the main study was 100% and 5% (in PEG 300) respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undliuted test item one week after the intradermal inductin. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.

B. CHALLENGE EXPOSURE
Two weeks after epidermal induction, the control and test animals were challenged by epidermal application of the test item in 5% PEF 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Challenge controls:
no
Positive control substance(s):
yes
Remarks:
Alpha-hexylcinnamaldehyde, 0.1% in PEG 300
Positive control results:
All test animals (at the 24-hour reading) and 6 out of 10 animals (at the 48-hour reading) showed discrete/patcht eryhema after the challenge treatment with alpha-hexylcinnamaldehyde, at 0.1% in PEG 300.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity, no mortality
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of systemic toxicity, no mortality.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5% in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of systemic toxicity, no mortality
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of systemic toxicity, no mortality.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the above mentioned findings in the adjuvant sensitisation test (M & K ) in guinea pigs, the test substance does not have to classified as a skin sensitiser.
Executive summary:

The Maximization test was perfomed in male guinea pigs (5 in control group, 10 in test group) to to assess the cutaneous allergenic potential of the test substance. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undliuted test item one week after the intradermal inductin. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.

Two weeks after epidermal induction, the control and test animals were challenged by epidermal application of the test item in 5% PEF 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

The results of the study are as follows: no deaths occurred and no toxic symptoms were evident in the guinea pigs of the control and the test group. None of the control and test animals showed skin reactions after the challenge treatment with the test item at 5% in PEG 300.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Skin sensitisation study (read-across):

The Maximization test was performed in male guinea pigs (5 in control group, 10 in test group) to assess the cutaneous allergenic potential of the test substance. The intradermal induction of sensitization in the test group was performed in the nuchal region with a 5% dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.

Two weeks after epidermal induction, the control and test animals were challenged by epidermal application of the test item in 5% PEF 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

The results of the study are as follows: no deaths occurred and no toxic symptoms were evident in the guinea pigs of the control and the test group. None of the control and test animals showed skin reactions after the challenge treatment with the test item at 5% in PEG 300.

Based on this GMPT test, the test substance was not considered to be a skin sensitizer.


Migrated from Short description of key information:
A GPMT is available on an analoguous substance of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid.
The substance gave a negative result in this test, indicative of the absence of skin sensitization properties.

Justification for selection of skin sensitisation endpoint:
Only one study is available to evaluate the potential of skin sensitization of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid (a read-cross is proposed with a analoguous substance).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

-


Migrated from Short description of key information:
-

Justification for selection of respiratory sensitisation endpoint:
-

Justification for classification or non-classification

No skin sensitization potential was showed in the GMPT performed on an analoguous substance of 2,2-bis(hydroxymethyl)-1,3-propanediol, ethoxylated and propoxylated, esters with acrylic acid. Therefore no classification is expected for the skin sensitization endpoint.