Registration Dossier

Administrative data

Description of key information

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester was tested in a guinea pig maximization test according to OECD Guideline 406.

30 female guinea pigs were used, 10 as control group and 20 were treated with the test material. The test material was dissolved in distilled water at a concentration of 100 mg/ml for induction. During the induction phase the test group animals were first treated with 3 double intradermal injections as follows: 1st: Freud's complete adjuvant (FCA) in distilled water (1:1), 2nd: test material in distilled water, 3rd: test material in distilled water and FCA (1:1). The 10 control animals received the same pairs of injections but in the 2nd injection only sesame seed oil was used.

After 7 days of intradermal injections the test material was applied undiluted for a period of 48 hours under an occlusive dressing.The same treatment was used on the 10 control animals using only distilled water.

21 days after the beginning of treatment a challenge phase was performed by applying undiluted test material on the left side, and distilled water on the right side for 24 hours under occlusive dressings for both test group and control group animals.

24, 48 and 72 hours after the beginning of the challenge application the animals were observed for erythema and oedema. No signs of erythema or oedema were observed in any of the animals.

Therefore the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester can be considered as non sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions, read-across
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was performed before REACH was in force.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding "Padre Antonio" Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Housing: in groups of ten in transparent polycarbonate cages (dimension: 590x385x200 mm)
- Diet: standard complete pellet diet supplied by MUCEDOLA ad libitum
- Water: filtered water from an automatic watering system ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-02 To: 1992-06-26
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
Induction phase: 100 mg/ml in distilled water, undiluted (epicutaneous)
Challenge phase: undiluted
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled water
Concentration / amount:
Induction phase: 100 mg/ml in distilled water, undiluted (epicutaneous)
Challenge phase: undiluted
No. of animals per dose:
20 test group
10 control group
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
INDUCTION EXPOSURE
Group 1: 1 FCA in distilled water (1:1), 2 test material in distilled water (1:1), 3 Test material in disitilled water and FCA (1:1), topical application test material
CHALLENGE PHASE: topical application of the test material (0.5 ml for 24 h)

INDUCTION EXPOSURE
Group 2: 1 1 FCA in distilled water (1:1), 2 distilled water, 3 distilled water and FCA (1:1), topical application of sesam seed oil
CHALLENGE PHASE: topical application of the test material (0.5 ml for 24 h)

- Control group
INDUCTION EXPOSURE:
1 0.1 ml FCA in distilled water (1:1); 2 0.1 ml distilled water, 3 0.1 ml distilled water and FCA (1:1)
CHALLENGE PHASE: topical application of the test material (0.5 ml for 24 h)

- Site: subscapolar region at the back
- Frequency of applications: on days 0 (intadermal) and 7 (epicutaneous) for 48 h, CHALLENGE on day: 21
- Concentrations: 100 mg/ml in sesame seed oil (intradermal), undiluted (epicutaneous)

CHALLENGE PHASE
- Test groups: occlusive patches with 0.5 ml test substance were applied to the right flanks, occlusive patches with 0.5 ml distilled water were applied to the left flanks

- Evaluation (hr after challenge): 24, 48 and 72 hours after start of challenge application
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

The evaluation after 24 hours after start of challenge showed also no signs of erythema or oedema in treated and control animals

Interpretation of results:
GHS criteria not met
Conclusions:
The test material Cosmacol ECI can be considered as non sensitising under the conditions described.
Executive summary:

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester was tested in a guinea pig maximazation test according to OECD Guideline 406.

30 female guinea pigs were used, 10 as control group and 20 were treated with the test material. The test material was dissolved in distilled water at a concentration of 100 mg/ml for induction. During the induction phase the test group animals were first treated with 3 double intradermal injections as follows: 1st: Freud's complete adjuvant (FCA) in distilled water (1:1), 2nd: test material in distilled water, 3rd: test material in distilled water and FCA (1:1). The 10 control animals received the same pairs of injections but in the 2nd injection only sesame seed oil was used.

After 7 days of intradermal injections the test material was applied undiluted for a period of 48 hours under an occlusive dressing.The same treatment was used on the 10 control animals using only distilled water.

21 days after the beginning of treatment a challenge phase was performed by applying undiluted test material on the left side, and distliled water on the right side for 24 hours under occlusive dressings for both test group and control group animals.

24, 48 and 72 hours after the beginning of the challenge application the animals were observed for erythema and oedema. No signs of erythema or oedema were observed in any of the animals.

Therefore the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester can be considered as non sensitizing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester was tested in a guinea pig maximization test according to OECD Guideline 406.

30 female guinea pigs were used, 10 as control group and 20 were treated with the test material. The test material was dissolved in distilled water at a concentration of 100 mg/ml for induction. During the induction phase the test group animals were first treated with 3 double intradermal injections as follows: 1st: Freud's complete adjuvant (FCA) in distilled water (1:1), 2nd: test material in distilled water, 3rd: test material in distilled water and FCA (1:1). The 10 control animals received the same pairs of injections but in the 2nd injection only sesame seed oil was used.

After 7 days of intradermal injections the test material was applied undiluted for a period of 48 hours under an occlusive dressing.The same treatment was used on the 10 control animals using only distilled water.

21 days after the beginning of treatment a challenge phase was performed by applying undiluted test material on the left side, and distliled water on the right side for 24 hours under occlusive dressings for both test group and control group animals.

24, 48 and 72 hours after the beginning of the challenge application the animals were observed for erythema and oedema. No signs of erythema or oedema were observed in any of the animals. Therefore the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tris(C12-13-branched-alkyl) ester can be considered as non sensitizing.

This result was supported with two studies on the analogues 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters and Tri (hexyl, octyl, decyl) citrate. Also in these studies were no sensitising effects seen.

The available information demonstrates a lack of skin sensitising properties of the test material 1, 2, 3 -Propanetricarboxylic acid, 2 -hydroxy-, tris (C12 -13 -branched-alkyl) ester.

Short description of key information:
The available information demonstrates a lack of skin sensitising properties of the test material 1, 2, 3 -Propanetricarboxylic acid, 2 -hydroxy-, tris (C12 -13-branched-alkyl) ester.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Justification for selection of respiratory sensitisation endpoint:
It is unlikely that the substance causes respiratory sensitisation because of the structural properties, the low vapour pressure and the lack of sensitsation in the skin sensitisation studies.

Justification for classification or non-classification

The available information demonstrates a lack of skin sensitising properties of the test material 1, 2, 3 -Propanetricarboxylic acid, 2 -hydroxy-, tris (C12 -13 -branched-alkyl) ester. No classification for sensitisation is indicated according to the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.