Hexanamide, N-(2-hydroxyethyl)-3,5,5-trimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

other: Acute Dermal Toxicity

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide

EC Number:

800-884-5

Cas Number:

1154308-86-7

Molecular formula:

C11 H23 N1 O2

IUPAC Name:

N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide

Test material form:

other: 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 UK, Margate
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 241.4 g to 292.9 g
- Fasting period before study: Not applicable
- Housing: Single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad liibitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 20°C
- Humidity (%): 47% to 57%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 31 July 2012 to 21 August 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Approximately 12.6 cm2
- % coverage: 3.3% to 3.6% of body surface
- Type of wrap if used: Semi-occlusive tape ("Micropore") and non-irritating occlusive tape ("Sleek")

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sterile water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hrs

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at least 5 times on the day of dosing, then daily for 14 days. Body weights on Days 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

No

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths occurred at this dose.

Mortality:

There were no unscheduled deaths during the study.

Clinical signs:

other: There were no signs of systemic toxicity and no local findings at the dose sites of any animal at any observation timepoint.

Gross pathology:

Macroscopic findings at necropsy were restricted to dark foci to all lobes of the lungs of one female, Animal No. 7. This finding is commonly observed in rats of this strain and age at these laboratories and is not considered to be related to administration of the substance.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the conditions of the study, the dermal LD50 value of the test substance in Sprague-Dawley rats was estimated to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, in Sprague-Dawley rats according to OECD Guideline 402, in compliance with GLP. A group of ten animals (five males and five females) was given a single, 24 h, occluded dermal application of the test substance to intact skin at a dose level of 2000 mg/kg bw. Animals were observed for signs of reaction to treatment from the day of dosing until the end of the observation period on Day 15. Body weights were recorded weekly and all animals were subjected to a necropsy examination. There were no unscheduled deaths. There were no systemic signs and no local findings at the dose sites noted in any animal at any observation timepoint. Body weight gain was considered to be acceptable for rats of this age and strain. No macroscopic abnormalities attributable to treatment with the substance were recorded at necropsy. Under the conditions of the study, the median lethal dermal dose level (LD50) was determined to be greater than 2000 mg/kg bw (Robertson, 2012).

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