Pentadecane, 7-methylene-

Endpoint summary

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Original study is classified as reliable without restriction (Klimisch 1) because it was conducted according to GLP and followed guidelines (OECD 401, U.S. EPA/TSCA) that were acceptable at the time the study was performed. It is rated K2 (with restrictions) as it is on a surrogate substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley, Incorporated
- Age at study initiation: 7 to 13 weeks
- Weight at study initiation: 200 to 299 grams
- Other: albino
- Fasting period before study: 18 hours
- Housing: Separated by sex, 5 per cage, housed in wire floor cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 to 74
- Humidity (%): 45 to 56
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 g/kg

Doses:

5 g/kg and 10 g/kg; individual doses were adjusted according to rat body weight.
10 g/kg: (Dose did not exceed more than 1.0 millilitre per 100 grams of body weight.) This dose level was split into two administrations, with one hour between doses

No. of animals per sex per dose:

5 male and 5 female dosed at 10 g/kg
5 male and 5 female dosed at 5 g/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 1, 2 and 14 days (additional observations were made is suggested by Neurotoxicologist.)
- Frequency of observations and weighing: Weighing occurred at 7 and 14 days after dosing.
- Necropsy of survivors performed: Yes

Statistics:

None reported

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

10 g/kg dose - 2/5 males and 2/5 females died
No lethality was observed at 5 mg/kg bw in either sex.

Clinical signs:

other: Several reported clinical signs were linked to excessive excretion of the compound including red extremities, unkempt appearance, discharge on perineal fur, greasy wet perineal fur and hindlimb regions, and alopecia and scabs on the perineal fur, hind lim

Gross pathology:

Necropsy revealed discoloration in lungs, intestines (with distention), liver (1 animal) and kidneys in rats that died or were sacrificed during the study period. Surviving animals had no remarkable gross lesions. No lesions were found in tissues taken to evaluate neurotoxicity (brains, spinal cords, sciatic nerves and pituitaries

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No histopathological signs of lesions were found in the central or peripheral nervous system. Clinical signs were not considered to be related to the irritation of the abdominal and hindlimb areas. Based on these results, Gulftene 16 did not appear to produce primary neurotoxicant effect.

Executive summary:

In an acute oral toxicity study, two groups of 10 (male and female) Sprague-Dawley albino rats, 7 to 13 weeks of age, which had fasted for 18 hours, were given a single oral dose of hexadec-1 -ene at 10 g/kg or 5 g/kg. These animals were observed for a total of 14 days. There was no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be >10 g/kg bw in both males and females. This result can be considered representative of the likely acute oral toxicity of the isomer 7 -methylenepentadecane.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

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

Justification for selection of acute toxicity – oral endpoint
Only available experimental study

Justification for classification or non-classification

Data is only available for a read across substance. The latter has a very low toxicity, with an LD50>10g/kg. It is not conceivable that the isomer 7 -methylenepentadecane would have a radically different acute toxicity to hexadec-1 -ene and it can be concluded with certaintiy that the latter will have an LD50>>2000mg/kg. The available data is sufficient for the purposes of classification and labelling and the conclusion is that classification for acute oral toxicity is not required.

Data is not required at this tier for acute toxicity by any other routes and is not available for this substance, so classification for other routes does not need to be considered