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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no details on test substance, test animals, environmental condition of animal room, body weight, pathology findings and method of LD50 calculation
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
2-methoxy-4-prop-1-enylphenyl acetate
EC Number:
202-236-1
EC Name:
2-methoxy-4-prop-1-enylphenyl acetate
Cas Number:
93-29-8
IUPAC Name:
2-methoxy-4-prop-1-en-1-ylphenyl acetate
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
2560, 3200, 4000 and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: No data
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 450 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 160 - <= 3 740
Mortality:
- 0/10, 5/10, 8/10 and 10/10 animals died at 2560, 3200, 4000 and 5000 mg/kg bw, respectively.
Clinical signs:
- Slight lethargy was observed in animals treated with 2560 mg/kg bw.
- Animals treated with 3200, 4000 and 5000 mg/kg bw showed lethargy and loss of righting reflex.
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

Table 7.2.1.1 – Distribution of mortality

 

Observation day

Dose (mg/kg bw)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2560

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3200

4

1

0

0

0

0

0

0

0

0

0

0

0

0

4000

6

0

1

1

0

0

0

0

0

0

0

0

0

0

5000

10

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, test material is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (3450 mg/kg bw)
Executive summary:

In an acute oral toxicity study, performed similarly to OECD Guideline No. 401, groups of rats (10/dose) were administered a single oral dose of test material at 2560, 3200, 4000 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.

 

All ten animals died at 5000 mg/kg bw. 5/10 and 8/10 animals died at 3200 and 4000 mg/kg bw. No mortality was observed at 2560 mg/kg bw. Slight lethargy was observed in animals treated with 2560 mg/kg bw. Animals treated with 3200, 4000 and 5000 mg/kg bw showed lethargy and loss of righting reflex.

 

Rat Oral LD50 = 3450 mg/kg bw (95 % confidence limits of 3160-3740 mg/kg bw)

Under the test conditions, test material is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw

- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (3450 mg/kg bw)

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.