Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
16th March 1988 to 26th April 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A GLP compliant study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The read-across is considered to be suitable based on the structural and 'mechanistic action' similarities between the target substance (3-(3-isopropenylphenyl)butanal) and source substance (3-(3-isopropylphenyl)butanal) and their similar physico-chemical properties.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3-(3-isopropylphenyl) butanal
- Physical state: liquid
- Smiles notation (if other than submission substance): c1(C(C)CC=O)cc(C(C)C)ccc1
- Structural formula attached as image file (if other than submission substance): see Fig. 1

Test animals

Species:
rat
Strain:
other: Fü-albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 5-6 weeks old
- Weight at study initiation: males: 107.3-130.6 g; females: 111.7-118.7 g
- Fasting period before study: approximately 18 hours
- Diet: NAFAG standard rat maintenance diet, No. 850 ad libitum
- Water: tap water ad libitum
- Acclimation period: seven days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 24th March 1988 To: 8th April 1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard Suspending Vehicle (SSV)
Details on oral exposure:
VEHICLE
- Standard Suspending Vehicle contains 5 g sodium carboxy methyl cellulose; 4 mL Tween 80; 5 mL benzylalcohol; 9 g sodium chloride; made up to 1000 mL in distilled water.

MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily (behaviour, vivacity, signs of injury, signs of sickness and abnormality); days 0, 4, 7, 12 and 15 (body weight)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, behaviour, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No incompatability reactions appeared.
Body weight:
No effect on bodyweight was observed.
Gross pathology:
No autopsy findings were seen.

Any other information on results incl. tables

ANALOGUE APPROACH JUSTIFICATION:

- See “Justification for read-across” document attached in section 13 for full details.

- In summary, important considerations for the use of read-across for acute toxicity are: i) 3-(3-isopropenylphenyl)butanal (the target substance) has similar physico-chemical properties as 3-(3-isopropylphenyl)butanal (the source substance), ii) there are structural similarities between the two substances, iii) the OECD QSAR Toolbox assigns very similar toxicity profiles to both substances, with any differences indicating that the source substance may be representative of a worst case scenario. The information reported in this summary is included to demonstrate comparability between the source (3-(3-isopropylphenyl)butanal) and target substance (3-(3-isopropenylphenyl)butanal).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute oral toxicity of the test material in rats was determined to be >2000 mg/kg. A single administration of the test material had no impact on the body weights of the test animals.
Executive summary:

Five male and five female Fü-albino rats (males: 107-131 g, females: 112 -119 g; about 5-6 weeks old) were randomly selected for an acute oral toxicity study. fasted rats were given a single dose of the test material suspended in Standard Suspending Vehicle (SSV) by gavage at a dose level of 2000 mg/kg bw. They were observed for 15 days for toxic signs including mortality and body weight changes. All rats were examined for gross lesions.

The acute oral toxicity of the test material in rats was determined to be greater than 2000 mg/kg, No deaths occurred. No incompatibility reactions were observed, No effects on the body weight development appeared. No autopsy findings were seen.