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Toxicological information

Acute Toxicity: oral

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
diarrhoea, depression, salivation
Body weight:
not reported
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.