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Administrative data

Description of key information

Key study: Bremer (1988), OECD 401: LD50 >2000 mg/kg bw  in males/females

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 1
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
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.
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.

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).

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
One study available with a Klimisch score of 2 which was assigned on the basis of read-across. The quality of the database is therefore high.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

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 and toxicological properties.


Justification for selection of acute toxicity – oral endpoint
Only one key study is available

Justification for classification or non-classification

According to Regulation 1272/2008 and Directive 67/548/EEC, the substance does not require classification for acute oral toxicity.

On the basis that the test material for the acute oral toxicity study (3-(3-isopropylphenyl)butanal, tradename Florhydral) is being used to support 3-(3-isopropenylphenyl)butanal (Dehydro Florhydral) on the basis of read-across, Dehydro Florhydral is also considered to be unclassified for acute oral toxicity.