Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

2017

Deviations:

no

Remarks:

No deviations ocurred that negatively impacted the integrity of the study.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine

EC Number:

701-270-9

Cas Number:

68911-25-1

Molecular formula:

N.A. UVCB substance

IUPAC Name:

Reaction product of Fatty acids, C18-unstaturated, dimer with 4,7,10-trioxa-1,13-tridecane-diamine

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3M Company, Lot 4293484
- Expiration date of the lot/batch:
31 January 2021
- Purity test date:
10 November, 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature protected from light
- Stability under storage conditions:
No data
- Stability under test conditions:
No data
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The test article was dosed neat.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: The test article was dosed neat.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 9-12 weeks old
- Weight at study initiation: 184-212
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, an imals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. The room in which the animals were kept was documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 (mean 21)
- Humidity (%): 40-64
- Air changes (per hr): 10 or greater
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06 May, 2019 To: 17 June, 2019

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x7 cm on the back of each rat
- % coverage: Approximately 10%
- Type of wrap if used: The test item was held in contact with the skin with a dressing, consisting of
a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of
Micropore tape was additionally used for fixation of the bandages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 24 hours after the start of exposure with water.
- Time after start of exposure: 24 hours.
OBSERVATION TIME POINTS : The skin reactions were assessed at approximately 24, 48 and 72
hours after the removal of the dressing and test item.
SCORING SYSTEM:
- Method of calculation: Draize

Duration of exposure:

24 hours

Doses:

- 2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings. Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days. All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing. Animals were weighed individually on Days 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight, gross pathology, irritation.

The skin reactions were assessed at approximately 24, 48 and 72 hours after the removal of the dressing and test item. Adjacent areas of untreated skin of each animal served as controls.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Preliminary study:

None.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at 2000 mg/kg.

Clinical signs:

other: No clinical signs of systemic toxicity were noted.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

Focal erythema, scales, scabs and/or necrosis was noted at the treated skin of the animals throughout the observation period. These local effects were considered not indicative of systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 value of MTDID 18990 in Wistar Han rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute dermal lethality potential of MTDID 18990 was evaluated in Wistar rats.  The study was conducted according to OECD 402, in compliance with OECD GLP.  Rats (3 female) received a single dermal application of 2000 mg/kg MTDID 18990; the test article was applied to clipped skin and held in contact with the body with surgical gauze covered with a Coban elastic bandage for 24 hours. All three rats survived the exposure period and subsequent 14-day recovery period. Focal erythema, scales, scabs and/or necrosis were noted at the treatment sites of the animals, but those were not considered indicative of systemic toxicity. No clinical signs of adverse systemic toxicity were observed. The rat dermal LD50 is>2000 mg/kg of body weight in rats.