Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 222-020-0 | CAS number: 3319-31-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Substances Act as described in the Federal Register, Section 1500.41 Federal Hazardous Substances Act Regulations - 16 CFR P 124
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- EC Number:
- 222-020-0
- EC Name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Cas Number:
- 3319-31-1
- Molecular formula:
- C33H54O6
- IUPAC Name:
- tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: stainless steel cages with elevated wire mesh flooring
- Diet (e.g. ad libitum): yes, Wayne 15% Rabbit Ration
- Water (e.g. ad libitum):yes, tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 +/- 2degrees F
- Humidity (%): 45+/- 5
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: 04 September 1981 To: 17 September 1981
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved back to provide an intact & abraded site
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM as supplied
- Concentration (if solution): 100%, used as supplied - Duration of treatment / exposure:
- 24h
- Observation period:
- 72h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back; one side abraded & one side intact.
- % coverage: Not reported
- Type of wrap if used: gauze patches covered by impervious material which was wrapped snugly around the trunk to secure the patches
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: 24h
SCORING SYSTEM: according to the Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Intact Skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Intact skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Intact skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Intact skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: Intact skin
- Remarks:
- Assessment at 24 and 72 h timepoints only (FHSA test)
- Irritant / corrosive response data:
- produced slight to well defined erythema when applied to the intact skin of rabbits. Recovery generally occurred within 72 hours
- Other effects:
- Not reported
Any other information on results incl. tables
Animal number |
Time |
Intact skin |
Abraded skin |
||
Erythema |
Oedema |
Erythema |
Oedema |
||
1 |
24 hours |
2 |
1 |
2 |
1 |
|
72 hours |
0 |
0 |
0 |
0 |
2 |
24 hours |
1 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
3 |
24 hours |
2 |
0 |
2 |
0 |
|
72 hours |
1 |
0 |
1 |
0 |
4 |
24 hours |
1 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
5 |
24 hours |
2 |
1 |
2 |
1 |
|
72 hours |
0 |
0 |
0 |
0 |
6 |
24 hours |
1 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the responses 24 & 72 hours after exposure to Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM as supplied it was not classified as a primary skin irritant to albino rabbits within the definition of the ACT reference: section 1500.3 (c) (4).
- Executive summary:
Acute dermal irritation has been assessed in the rabbit using FHSA test methods with a 24 hour exposure.
The irritation observed was not of sufficient severity or persistence for the substance to require classification as a skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
