Registration Dossier

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
Reference
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:
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 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

 

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
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

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

 

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

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.