Registration Dossier
Registration Dossier
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EC number: 222-020-0 | CAS number: 3319-31-1
Endpoint summary
Administrative data
Description of key information
Skin irritation: Not irritant
Eye irritation: Not irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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 - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- 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 125
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Not reported
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated & acted as a control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7d
- Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure:N/A
SCORING SYSTEM: Draize (see table below)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: No data - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tris (2-ethylhexyl)trimellitate (TOTM) is not a primary ocular irritant within the definition of the Act Referenced 1500.42 (b) (1) (2).
- Executive summary:
Acute eye irritation has been assessed in the rabbit using FHSA methods.
The severity and persistence of ocular response was not sufficient for the substance to require classification as an eye irritant
Reference
Animal number |
Time |
Cornea |
Iris inflammation |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
1 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
2 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
3 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
4 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
1 |
0 |
0 |
5 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
0 |
0 |
0 |
1 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 hours |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
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.
Acute eye irritation has been assessed in the rabbit using FHSA methods.
The severity and persistence of ocular response was not sufficient for the substance to require classification as an eye irritant
Justification for classification or non-classification
Observed response in both a skin irritation study and an eye irritation study was not of sufficient severity or persistence to require classification.
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.
