Reaction mass of (9E)-9-Undecenal and (9Z)-9-Undecenal and undec-10-enal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1971

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Pre-GLP study following a method similar to a recognised guideline. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enal

EC Number:

203-973-1

EC Name:

Undec-10-enal

Cas Number:

112-45-8

Molecular formula:

C11H20O

IUPAC Name:

10-undecenal

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150 - 300 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: derived from the initial screening study.

Doses:

5000 mg/kg

No. of animals per sex per dose:

screening study: 2
main test: 8

Control animals:

no

Details on study design:

Initially two rats (fasted overnight) were used for screening purposes. They were given a single dose of 5 ml. or 5000 mg/kg of body weight by gastric intubation. Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days. Where the results indicated the test compound to be relatively nontoxic. (i.e., no deaths occurred), a group of eight additional rats was given the same dose via the same route. Following the above primary screening studies, the LD50 value was determined if one or two animals died within 48 hours in the initial screening (i.e., the first pair of animals) or if the incidence of death was greater than two of the total of 10 rats within the 14-day observation period. The LD50 value was determined using six groups of rats (five rats per group fasted overnight) by giving graded dosage levels of the test compounds via the same route. Toxic signs and mortality were recorded immediately following dosing and once daily thereafter for 14 days. The LD50 value was calculated according to Horn's method. A gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality was observed

Clinical signs:

other: diarrhoea, depression, salivation

Gross pathology:

no gross findings

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 study the acute oral LD50 of this test material is > 5000 mg/kg.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague Dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, once only by gavage. A screening study was performed with 2 test animals to determine the dose used in the main test. In the main test, 8 test animals were dosed at 5000 mg/kg body weight. Mortality and clinical signs were monitored during the study. All animals were subjected to gross necropsy after an observation period of 14 days. There were no deaths but clinical effects observed were diarrhoea, depression and salivation. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight.