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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1941
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only basic data given but sufficient to establish reliability as a key study when the information in the publication and original study report are combined. Publication contains method details, study report details on mortality per animal.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1939
Report Date:
1939
Reference Type:
publication
Title:
The single dose toxicity of some glycols and derivatives
Author:
Smyth HF, Seaton J, Fischer L
Year:
1941
Bibliographic source:
J Ind Hyg Toxicol 23(6) p259-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Pre-dates guideline studies but basic principles followed although lacking in non-lethal observations, histopathology and secondary observations now normally performed.
GLP compliance:
no
Remarks:
study pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Commercial grade

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: albino
- Source: single source used
- Weight at study initiation: 90-120g
- Fasting period before study: 18 hours approximately
- Diet (e.g. ad libitum): Purina chow supplemented by fresh vegetables
- water: ad libitum


ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% Tergitol in water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5ml
Maximum concentration: 50%

Test material was dispersed in 1% "Tergitol" penetrant7 (sodium sulphate of heptadecyl alcohols) in order to achieve the desired concentration in vehicle.
Doses:
no data
No. of animals per sex per dose:
10
Control animals:
other: no data but large number of substances tested in study which acted as comparative controls.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data.
- Necropsy: only on animals where deaths were not consistent with others receiving substance in order to eliminate those dying from infections. No necropsy of survivors. No histopathology performed on any animal.
- Other examinations performed: none reported.
Statistics:
LD50s calculated by method of probits according to Bliss (Ann Appl Biol, 22, 134-167 (1935), Quart J Pharm Pharmacol, 11, 192-216 (1938)). The sclope of the dose mortality line when plotted by the probit method was calculated.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
11 920 mg/kg bw
95% CL:
> 10 880 - < 13 100
Mortality:
Most deaths occured within 1 day.
Clinical signs:
Fatal or near fatal doses produced narcosis signs of sluggishness and depressed functioning
Body weight:
Spread of values prevented any significant interpretation.
Gross pathology:
Bile was red or orange and there was evidence of effects on liver, kidney and spleen. Stomachs were congested and injected when animals died soon after dosing.

Any other information on results incl. tables

The slope of the probit plot (dose/response curve) was 14260. The toxicity was lower than that of the parent glycol ether 2 -(2 -butoxyethoxy)ethanol and it was speculated that this could be due to the low water solubility of the substance impairing absorption.

Results per dose:

Dose

Deaths/number of animals

Average weight change (SD) g

15

5/6

+21 (one animal)

12

5/10

+25 (11)

10

1/10

+9 (23)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is of low toxicity to rats.
Executive summary:

In a single dose acute oral toxicity study, male Wistar albino rats were exposed to 2 -(2 -butoxyethoxy)ethyl acetate. The LD50 value is shown below. Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines.

Results synopsis

LD50: ~12000mg/kg