Nonanamide, N,N-dimethyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 April 2017 to 19 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Genagen PA/ N,N-Dimethylnonanamide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

OECD Guidelines for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity” adopted on 24 February 1987

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

N,N-dimethylnonanamide

EC Number:

612-975-5

Cas Number:

6225-08-7

Molecular formula:

C11H23NO

IUPAC Name:

N,N-dimethylnonanamide

Details on test material:

- Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)

FORM AS APPLIED IN THE TEST
The test item applied topically (dermal exposure) as such

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 Weeks
- Weight at study initiation: 217.93 g to 231.98 g (males); 201.61 g to 207.91 g (females)
- Housing: Individual in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet - Pellet
- Water (e.g. ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period: Start: 13 April 2017; End: 17 April 2017

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4°C to 23.4°C
- Humidity (%): 44% to 64%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle

IN-LIFE DATES: From: 13 April 2017; To: 02 May 2017

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorso-lateral area of the trunk
- % coverage: 10% of the total body surface
- Type of wrap if used: Crepe bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Washed with distilled water and dried with absorbent cotton
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied:2000 mg/kg body weight

Duration of exposure:

24 hours

Doses:

2000 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: Clinical signs daily once and weekly once weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable

Results and discussion

Preliminary study:

Clinical Signs of Toxicity and Mortality: The animals did not reveal any clinical signs of toxicity and mortality during the observation period and did not reveal any skin reactions.

Body Weight and Percent Change in Body Weight with Respect to Day 1: The body weight and percent change in body weight with respect to Day 1 of all the animals were increased during the observation period.

Pathology: No treatment related gross pathological findings were observed in any of the animals sacrificed at the end of the experimental period.

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:

No mortalities were noted

Clinical signs:

other: No Clinical signs were noted

Gross pathology:

No gross pathological findings were observed in any of the animals

Other findings:

- Organ weights: Not applicable
- Histopathology: Not applicable
- Potential target organs: Not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 402. Rats were treated semioccusively at dose of 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of Genagen PA was investigated according to the Guideline OECD 402. Rats were treated semioccusively at dose of 2000 mg/kg bw for 24h. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.