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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 March 2016 to 30 March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
2-(tetrapropenyl)succinic acid, monoester with propane-1,2-diol
EC Number:
257-836-6
EC Name:
2-(tetrapropenyl)succinic acid, monoester with propane-1,2-diol
Cas Number:
52305-09-6
Molecular formula:
C17H30O5 - C21H38O5
IUPAC Name:
2-[2-(2-hydroxy-1-methylethoxy)-2-oxoethyl]tetradecanoic acid
Test material form:
solid
Details on test material:
- Apperance: Yellow solid block
- Storage: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation: Weight ranged between 202 - 247 g. The weight variation did not exceed ±20 % of the mean weight for each sex.
- Housing: The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-Hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST MATERIAL PREPARATION
For the purpose of the study the test item was weighed out according to each animal's individual body weight and moistened with arachis oil BP prior to application.

TEST SITE
- Area of exposure: The back and flanks of each animal.
- % coverage: Applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area)
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The dressings were examined to ensure that they were securely in place shortly after dosing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.

TEST MATERIAL
- For solids, paste formed: The appropriate amount of test item was applied moistened with arachis oil BP.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five male and five female rats.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes. At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no deaths reported.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
Animals showed expected gains in body weight, except for one female which showed no gain in body weight during the first week but expected gain in body weight during the second week.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
DERMAL REACTIONS
Signs of dermal irritation were very slight to well-defined erythema, very slight to slight oedema, haemorrhage of dermal capillaries, light brown discoloration of the epidermis, crust formation, loss of skin leas and flexibility, hardened light brown coloured scab, scab cracking, scab lifting to reveal glossy skin, desquamation and glossy skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

The acute dermal toxicity of the test material was assessed in the Wistar strain rat in accordance with the standardized guidelines OECD 402 and EU Method B.3 under GLP conditions.

A limit test was conducted to assess the potential of the test material to cause acute dermal toxicity in the Wistar strain rat. A group of ten animals (five males and five females) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths or signs of systemic toxicity associated with the test material.

Signs of dermal irritation were very slight to well-defined erythema, very slight to slight oedema, haemorrhage of dermal capillaries, light brown discoloration of the epidermis, crust formation, loss of skin elasticity and flexibility, hardened light brown coloured scab, scab cracking, scab lifting to reveal glossy skin, moderate desquamation and glossy skin. Animals showed expected gains in body weight, except for one female which showed no gain in body weight during the first week but expected gain in body weight during the second week.

No abnormalities were noted at necropsy.

Under the conditions of the study, the acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.

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