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EC number: 603-303-1 | CAS number: 128819-84-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
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- Flash point
- Auto flammability
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 - 27 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / (temperature and relative humidity above ranges from OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- / (temperature and relative humidity above ranges from OECD 406)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 30 May 2008
- Deviations:
- yes
- Remarks:
- / (temperature and relative humidity above ranges from OECD 406)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- yes
- Remarks:
- / (temperature and relative humidity above ranges from OECD 406)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI, Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Budapest, Hungary
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Based on the physico-chemical properties, the test substance is suspected to be a surface active substance. Thus, according to OECD TG 429 (§5), a GPMT was performed instead of a LLNA due to the known limitations of the LLNA that may necessitate the use of OECD TG 406 (e.g. false positive findings with certain skin irritants [such as some surfactant type chemicals].
Test material
- Reference substance name:
- Reaction products of trimethylolpropane triglycidyl ether and acrylic acid
- EC Number:
- 603-303-1
- Cas Number:
- 128819-84-1
- Molecular formula:
- C18 H30 O9, C21 H35 Cl O10, C24 H38 O12 and C27 H43 Cl O13 (mainly)
- IUPAC Name:
- Reaction products of trimethylolpropane triglycidyl ether and acrylic acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light and humidity
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: CRL:HA Guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: about 10 weeks old
- Weight at study initiation: 462 – 517 g
- Housing: 5 animals of the same sex per cage in macrolon cages, laboratory bedding, Lignocel 3/4-S (J. Rettenmaier & Söhne GmbH+CO.KG, Rosenberg, Germany)
- Diet: Cunigra Diet for Rabbits (# NN16201718, Bonafarm-Bábolna Takarmány Ltd., Hungary), ad libitum
- Water: tap water (containing 50 mg/100 mL ascorbic acid), ad libitum
- Acclimation period: 41 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 25.0
- Humidity (%): 31 - 84%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/ 12
- IN-LIFE DATES: From: 28 June To: 27 Aug 2016
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 5% (w/v) ethanol and 0.1% (w/v) Polysorbate 80 in physiological saline
- Concentration / amount:
- 0.5%
0.1 mL/ injection site - Day(s)/duration:
- single injection
- Adequacy of induction:
- other: 0.5% (w/v) test item in the vehicle caused no more than mild-to-moderate erythema (graded with score 1), therefore this concentration was chosen in the main study.
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
closed patch saturated with 0.5 g of test item - Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% and 50% (safeguard dose, dissolved in ethanol:sesame oil 1:3 mixture with 1% (w/v) Polysorbate 80)
0.5 mL - Day(s)/duration:
- 24 h
- Adequacy of challenge:
- other: non irritant concentration
- No. of animals per dose:
- Testgroup: 10 females
Control group: 5 females
Range finding test: 8 females - Details on study design:
- RANGE FINDING TESTS:
- intradermal injections:
site 1: 0.5% test substance (in intradermal vehicle = 5% (w/v) ethanol and 0.1% (w/v) Polysorbate 80 in physiological saline)
site 2: 1% test substance (in intradermal vehicle)
site 3: 2.5% test substance (in intradermal vehicle)
site 4: 5% test substance (in intradermal vehicle)
site 5: 5% test item was also tested in a 1:1 mixture (v/v) of Freund's Complete Adjuvant and physiological saline solution
0.1 mL of each concentration were injected into shaved skin of two guinea pigs.
- epidermal applications: 25, 50, 75 % (in dermal vehicle = ethanol:sesame oil 1:3 (v/v) mixture with 1% (w/v) Polysorbate 80) and 100% (undiluted). 0.5 mL of the test article (diluted) or 0.5 g (undiluted) were applied to hair-free scapular area of each guinea pig via a sterile gauze patch (2.5x2.5 cm, 4 layers of porous gauze pads). A surrounding adhesive hypoallergenic plaster held the patches in place. The treated areas were covered for 48 h with a fully occlusive foil (Closed Patch Test).
After the patch removal any remaining test substance was removed with 70% (w/v) ethanol using a gauze swab.
1, 2.5 and 5% (w/v) test item (in vehicle) caused haemorrhagic skin lesions at the treatment site that developed to wounds, therefore 0.5% (w/v) test item (in vehicle), which caused no more than mild-to-moderate erythema (graded with score 1) was chosen for the main study.
It was found that all the dermal treatments at the tested concentrations produced no reaction on the skin of guinea pigs.
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 (three pairs of injections; 0.1 mL/site):
Injection 1: 1:1 mixture (v/v) of FCA and physiological saline solution
Injection 2: 0.5% test substance (in intradermal vehicle)
Injection 3: 0.5 % test substance, emulsified in a 1:1 mixture (v/v) of FCA and physiological saline solution
Epicutaneous:
Since the undiluted test item was not skin irritating in the dermal dose range-finding study, the test area was painted with 0.5 mL of 10% sodium dodecyl sulphate in Vaseline 24 h prior to the topical induction application. A 2.5x2.5 cm sterile gauze patch (4 layers of porous gauze pads) was saturated with approximately 0.5 g of the undiluted test item and placed over the injection sites. A surrounding adhesive hypoallergenic plaster held the patches in place. The treated areas were covered for 48 h with a fully occlusive foil (Closed Patch Test). After the patch removal any remaining test substance was removed with 70% (w/v) ethanol using a gauze swab.
- Control group:
Intradermal (three pairs of injections, 0.1 mL/site):
Injection 1: 1:1 mixture (v/v) of Freund's Complete Adjuvant abd physiological saline solution
Injection 2: intradermal vehicle
Injection 3: intradermal vehicle, emulsified in a 1:1 mixture (v/v) of Freund's Complete Adjuvant abd physiological saline solution
Epicutaneous:
The test area was painted with 0.5 mL of 10% sodium dodecyl sulphate in Vaseline 24 h prior to the topical induction application. A 2.5x2.5 cm sterile gauze patch (4 layers of porous gauze pads) was saturated with 0.5 mL of the dermal vehicle only and placed over the injection sites. A surrounding adhesive hypoallergenic plaster held the patches in place. The treated areas were covered for 48 h with a fully occlusive foil (Closed Patch Test).
Local effects were examined and scored 1, 24, 48 and 72 hours after the treatment or after patch removal.
- Site: scapular region
- Frequency of applications: every 7 days
- Duration: days 0-14
- Concentrations: 0.5% (intradermal) and 100% (epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: 100 and 50% test substance
- Control group: 100 and 50% test substance
- Site: shaved left and right side of respective animal
- Concentrations: 100% (left side) 50% (right side; safeguard dose)
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- the control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (reliability study)
Results and discussion
- Positive control results:
- The selection of dose levels for 2-Mercaptobenzothiazole was set on the basis of the previous reliability study.
Intradermal induction exposure: 1% (w/v) (in vehicle (1% methyl cellulose in distilled water)
Dermal induction exposure: 75% (w/v) (in vehicle)
Challenge treatment: 50% (w/v) (in vehicle)
Challenge with 2-Mercaptobenzothiazole resulted in a positive response in test animals previously sensitised. The net response values at the 24 and 48 h observations represented an incidence rate of 80% and 70% and net score values of 0.80 and 0.70 respectively. In the control animals no visible changes were found after 24 or 48 h of examinations following challenge with the reference item. The dermal scores represented discrete erythema (score 1) developed on the skin of sensitised guinea pigs.
On the basis of the results of the reliability check study, the reference item 2-Mercaptobenzothiazole was classified as a skin sensitizer and thus, the results proved the validity of the experimental procedure and the test system used.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.5% challenge: 100%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0% challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.5% challenge: 100%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.5% challenge: 50%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0% challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction: 0% challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 0.5% challenge: 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Animals were treated with a 10 % Sodium Dodecyl Sulphate solution 24 h prior to the epicutaneous induction.
Any other information on results incl. tables
Range finding test
Table 1: Results after intradermal injection (Range finding test)
Animal No. |
Concentration (w/v) [%] |
Reaction scores after [h] |
|||||||
1 |
24 |
48 |
72 |
||||||
E |
O |
E |
O |
E |
O |
E |
O |
||
1 |
5 (in FCA:saline) |
2 |
2 |
2 |
1 |
2 |
0 |
2 |
0 |
2 |
2 |
2 |
2 |
1 |
2 |
0 |
2 |
0 |
|
1 |
5 (in intradermal vehicle) |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
|
1 |
2.5 (in intradermal vehicle) |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
|
1 |
1 (in intradermal vehicle) |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
|
1 |
0.5 (in intradermal vehicle) |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
E = erythema
O = oedema
Intradermal vehicle = 5% (w/v) ethanol and 0.1% (w/v) Polysorbate 80 in physiological saline
Additional information on results (Range finding test)
A) Intradermal Induction
In addition to the erythema and/or oedema observed (see Table 1), whitish to brownish skin lesions were observed in 2/2 animals treated with 5% (in FCA:saline) at any reading time point.
Haemorrhagic skin lesions and/or wounds were observed in the 2/2 animals treated with 2.5 and 5% (in intradermal vehicle) and 1/2 animals treated with 1% of the test substance at 24 h persisting at least until 72 h after treatment.
No local reactions (oedema or erythema) were visible after treatment with theb lowest concentration (0.5% test substance). Thus, a concentration of 0.5% was selected for intradermal induction.
B) Epicutaneous Induction
No local reactions (oedema or erythema) were visible after topical application of 25, 50, 75 (in dermal vehicle*) or 100% test substance (undiluted), neither after 1 nor after 24 or 48 or 72 h after the removal of the dressing.
*Dermal vehicle = ethanol:sesame oil 1:3 (v/v) mixture with 1% (w/v) Polysorbate 80 in physiological saline
Main study
Table 2: Skin response after intradermal induction with intradermal vehicle (control group) or test substance (100 % in intradermal vehicle, test group)
Animal No. |
Group |
Reaction scores after 24 h |
|
E |
O |
||
1 |
control |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
4 |
0 |
0 |
|
5 |
0 |
0 |
|
6 |
test |
1 |
0 |
7 |
1 |
0 |
|
8 |
1 |
0 |
|
9 |
1 |
0 |
|
10 |
1 |
0 |
|
11 |
1 |
0 |
|
12 |
1 |
0 |
|
13 |
1 |
0 |
|
14 |
1 |
0 |
|
15 |
1 |
0 |
Additional information on results (Main study)
A) Skin response after intradermal induction with intradermal vehicle (control group) or test substance (100 % in intradermal vehicle, test group)
All animals of the test group showed local reactions visible as erythema (graded with score 1),. No local reactions (oedema or erythema) were observed in the control group.
B) Skin response after epidermal induction of the dermal vehicle or test substance (100 %)
Animals were treated with a 10 % sodium-lauryl-sulphate 24 h prior to the epidermal induction application.
Except after the reading time point of 1 h, where 6/10 animals of the test group showed skin erythema (graded with score 1), no local reactions (oedema or erythema) were observed after topical application of the dermal vehicle (control group) or 100% test substance (test group), neither after 24, 48 or 72 h after removal of the dressing.
Challenge
Table 3: Skin response (Erythema) after challenge (treated with 100% or 50% test substance)
|
Group |
Reaction scores after removal of the dressing |
|||
Reading time point |
24 h |
48 h |
|||
Concentration [%] |
100 |
50 |
100 |
50 |
|
Animal No. |
|
||||
1 |
control |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
|
6 |
test |
1 |
1 |
1 |
0 |
7 |
1 |
0 |
1 |
0 |
|
8 |
1 |
2 |
1 |
1 |
|
9 |
1 |
0 |
1 |
0 |
|
10 |
1 |
1 |
1 |
0 |
|
11 |
1 |
1 |
1 |
0 |
|
12 |
2 |
2 |
2* |
2* |
|
13 |
2 |
2 |
1 |
0 |
|
14 |
2 |
2 |
1 |
1 |
|
15 |
0 |
0 |
0 |
0 |
* dry skin
Mortality /viability/systemic effects
No mortalities or signs indicative for systemic or local toxicity were observed.
No histopathological evaluation was performed after the sacrifice of the animals.
Clinical observations showed no abnormalities.
Body weights
Table 4: Body weights [g]
|
Animal No. |
Day(s) relative to start date |
||||
-1 |
7 |
14 |
21 |
25 |
||
Control group |
1 |
478 |
562 |
507 |
516 |
513 |
2 |
496 |
523 |
547 |
571 |
575 |
|
3 |
467 |
490 |
456 |
499 |
494 |
|
4 |
487 |
481 |
546 |
563 |
545 |
|
5 |
517 |
479 |
588 |
612 |
620 |
|
Mean |
|
489 |
507 |
528.8 |
552.2 |
549.4 |
SD |
19 |
35.5 |
49.8 |
45.2 |
50.1 |
|
Test group |
6 |
490 |
511 |
498 |
593 |
564 |
7 |
462 |
493 |
471 |
527 |
521 |
|
8 |
501 |
529 |
499 |
570 |
553 |
|
9 |
501 |
522 |
517 |
579 |
558 |
|
10 |
477 |
512 |
493 |
565 |
546 |
|
11 |
470 |
472 |
504 |
534 |
540 |
|
12 |
482 |
491 |
510 |
532 |
525 |
|
13 |
475 |
500 |
489 |
526 |
501 |
|
14 |
485 |
488 |
490 |
534 |
516 |
|
15 |
514 |
482 |
486 |
536 |
523 |
|
Mean |
|
485.7 |
500 |
495.7 |
549.6 |
534.7 |
SD |
16 |
18.2 |
13 |
24.6 |
20.5 |
The body weight gain of the animals was not affected adversely during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- CLP: Skin sens 1A
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