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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1967
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth, H. et al.
Year:
1969
Bibliographic source:
Am Ind Hyg Assoc J. 30(5):470-6

Materials and methods

Principles of method if other than guideline:
The test material was administered to rabbits under an occlusive dressing for 24 h.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): triethylene glycol diacetate
- Physical state: liquid
- Analytical purity: no data
- Identification: 30-WML-64, 28-DS-56-7
- Sample No.: 30-111

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The fur was removed from the entire trunk by clipping.
- Type of wrap if used: The test material was retained beneath an impervious plastic film.
Duration of exposure:
24 h
Doses:
First experiment
2, 4, 8 and 16 mL/kg bw
Second experiment
8 and 16 mL/kg bw
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- The animals were immobilized during the contact period
Statistics:
Based upon mortalities the most probable LD50 value and its fiducial range are estimated by the method of Thompson W.R. (1947) using the tables of Weil G.S. (1952). Where possible, in parentheses limits of ± 1.96 standard deviations are given while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
8 mL/kg bw
Based on:
test mat.
95% CL:
1.91 - 33.5
Sex:
male
Dose descriptor:
LD50
Effect level:
9 040 mg/kg bw
Based on:
test mat.
Remarks on result:
other: dose value as calculated from relative density of 1.13
Mortality:
First experiment:
16 mg/kg bw: 3/4 animals died 4 days after treatment
Second experiment:
No mortality occurred during the study period.
Clinical signs:
First and second experiment:
No clinical signs of toxicity were observed up to the end of the observation period (no information about length, at least 8 days).
Body weight:
First experiment:
16 mL/kg bw: the surviving animal showed an increase in body weight
8 mL/kg bw: one surviving animal showed an increase in body weight, the other surviving animal showed a decrease in body weight
Second experiment:
All animals had depressed body weight (no further information).
4 mL/kg bw: one surviving animal showed an increase in body weight, two surviving animals showed a decrease in body weight
2 mL/kg bw: one surviving animal showed an increase in body weight, two surviving animals showed a decrease in body weight
Gross pathology:
First experiment:
Congestion of the liver and kidneys (no further information). Effect of the lungs in one animal (no further information).
Second experiment:
Pathology revealed no substance-related findings.
Other findings:
First experiment:
Skin irritation was obvious in the high dose group and described as marked erythema (no further information).
Second experiment:
No skin irritation or other findings are reported.

Any other information on results incl. tables

Table 1. Results of the first acute dermal toxicity experiment.

Dose
[mL/kg bw]
Toxicological results* Time of death Mortality (%)
16 3/0/4 Day 4 75
8 2/0/4 Day 4 and Day 8 50
4 1/0/4 Day 4 25
2 1/0/4 Day 4 25

Table 2. Results of the second acute dermal toxicity experiment.

Dose
[mL/kg bw]
Toxicological results* Time of death Mortality (%)
16 0/0/4 - -
8 0/0/4 - -

* first number = number of dead animals

second number = number of animals with clinical signs

third number = number of animals used

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified