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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 23 - November 04 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:
according to
Guideline:
other: Federal Insecticide, fungicide & rodenticide Act part 163, Title 40; Code of the federal Regulations 40 CRF 163.81 & Principles & procedures for evaluating the toxicity of household substances Publication 1138, National Academy of Sciences-National Resear
GLP compliance:
yes
Test type:
other: Limit Test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nuoplaz 6959 (Tris (2-ethylhexyl)trimellitate)
- Physical state: liquid
- Analytical purity: 98.95%
- Impurities (identity and concentrations): 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Composition of test material, percentage of components: Tris (2-ethylhexyl)trimellitate, 2-ethylhexanol 0.05%, miscellaneous esters 1.00%
- Lot/batch No.: 39049

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Becker Centalia Kansas USA
- Weight at study initiation: 2.3-3.2 Kg
IN-LIFE DATES: From: October 22 To: November 04

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back with longitudinal abrasions over the exposure area. Abrasions penetrated the stratum corneum but not deeply enough to cause bleeding
- % coverage: 10
- Type of wrap if used: gauze covered by rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes area wiped
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 ml/kg
- Concentration (if solution): 100% (as supplied)
- Constant volume or concentration used: yes/no constant concentration
- For solids, paste formed: yes/no: N/A

VEHICLE: N/A
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24h
Doses:
2.0 ml/kg
No. of animals per sex per dose:
3 male & 3 females in TOTM group
2 males & 2 females in control group
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days (or other?): 14d
- Frequency of observations and weighing: weighing on d 1, 7, 14
- Necropsy of survivors performed: yes/no: yes d15
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Statistics:
No. N/A single dosage used.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits calculable as no mortality
Mortality:
None
Clinical signs:
No signs of toxicity seen during exposure & subsequent observation periods
Body weight:
No effects of exposure on body weight. All animals gained weight on days 7 & 14.
Gross pathology:
No observed abnormalities at necropsy.

Any other information on results incl. tables

Mean (±SD) Body weights (g) of 3 male & 3 female rabbits exposed to 2.0 ml/kg TOTM and 2 male & 2 female control rabbits

Intervals

Males

Females

 

Control1

TOTM 2.0 ml/kg

Control1

TOTM 2.0 ml/kg

 

 

 

 

 

Pre-exposure

3.2

2.33 ± 0.06

2.8 ± 0.14

2.37 ± 0.06

Day 7

3.4

2. 30 ± 0.10

3.1± 0.07

2.53 ± 0.06

Day 14

3.6

2.46 ± 0.06

3.2 ± 0.14

2.67 ± 0.06

 

 

 

 

 

1Controls were untreated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test TOTM has an acute dermal LD50 in rabbits of >2.0 ml/kg.
Executive summary:

Acute dermal toxicity (LD50) in the rabbit is in excess of 2 mL/kg