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Toxicological information

Skin irritation / corrosion

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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:
1981
Report Date:
1981

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tris (2-ethylhexyl)trimellitate/Nuoplaz 6959/TOTM
- Molecular formula (if other than submission substance): C33 H54 O6
- Molecular weight (if other than submission substance): 546.79
- Smiles notation (if other than submission substance): c1(c(ccc(c1)C(OC[C@@H](CCCC)CC)=O)C(OC[C@@H](CCCC)CC)=O)C(OC [C@@H](CCCC)CC)=O
- InChl (if other than submission substance): 1S/C33H54O6/c1-7-13-16-25(10-4)22-37-31(34)28-19-20-29(32(35)38-23-26 (11-5)17-14-8-2)30(21-28)33(36)39-24-27(12-6)18-15-9-3/h19-21,25-27H,7-18,22- 24H2,1-6H3
- Structural formula attached as image file (if other than submission substance): see 3319-31-1 structure.png

Test animals

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

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.