Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

EC Number:

947-818-2

Cas Number:

1612783-92-2

Molecular formula:

C15H28O2

IUPAC Name:

Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 6
- Expiration date of the lot/batch: No data
- Purity test date: 04 October, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In a room with controls set to maintain 18°C to 24°

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, dosed neat

FORM AS APPLIED IN THE TEST: Neat, clear colorless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 12 weeks old
- Weight at study initiation: Males: 434-500 g , Females: 280-310
- Fasting period before study: None
- Housing: Upon arrival, all animals were housed individually in clean, stainless steel, wire-mesh cages suspended above cage-board. Each cage was clearly labeled with a color-coded cage card indicating study number, group number, cage number, dosage level, animal number(s), and sex. Animals were maintained in accordance with the Guide for the Care and Use of Laboratory Animals.
- Diet (e.g. ad libitum): PMI Nutrition International Certified Rodent LabDiet, ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 C
- Humidity (%): 30-70
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16 July, 2018 To: 30 July, 2018

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal skin
- % coverage: 10
- Type of wrap if used: The application site was covered with 2-ply gauze which was held in place by tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped with disposable paper towels moistened with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):5000 mg/kg (5.814 mL/kg body weight)

VEHICLE: None

Duration of exposure:

24 hours

Doses:

5,000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at the time of dosing and approximately 1, 2, and 4 hours post-application on Day 0 and once daily thereafter for 14 days. The application sites were examined for erythema, edema, and other dermal findings beginning approximately 30-60 minutes after bandage removal and daily thereafter through Day 14. The areas of application were clipped free of hair on the day prior to dosing and as needed to facilitate accurate dermal observations.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality was observed.

Clinical signs:

other: No test substance-related clinical signs were observed.

Gross pathology:

There were no test substance-related macroscopic findings at the scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the dermal LD50 of the test article is greater than 5,000 mg/kg body weight.

Executive summary:

The acute dermal lethality of the test article was evaluated in male and female Sprague Dawley rats. The study was conducted according to OECD 402 (1987) in compliance with OECD GLP regulations. The test article (5,000 mg/kg body weight) was administered once dermally under semi-occlusive dressing for 24 hours to clipped, unabraded dorsal skin of 5 male and 5 female rats. Mortality, clinical observations, dermal findings, and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy. There were no deaths, remarkable body weight changes, or test substance-related clinical findings or gross necropsy findings. Based on the results of the study, the dermal LD50 of the test article is greater than 5,000 mg/kg body weight.