Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
No deviations occurred that impacted the integrity of the study.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 38015
- Expiration date of the lot/batch: April 20, 2018
- Purity test date: April 20, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: reported as "Room temperature and humidity"

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was individually weighed and moistened with distilled water to form a paste consistency.

FORM AS APPLIED IN THE TEST: Moistened with water to form a paste.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Stone RIdge, NY
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: Male range: 263-282 g, Female range: 208-229 g
- Fasting period before study: None
- Housing: Individually in suspended wire-bottom cages.
- Diet (e.g. ad libitum): PMI Rat Chow (Diet No. 5012) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data in final report but it did not deviate from the guideline-specified temperature range.
- Humidity (%): No data in final report but it did not deviate from the guideline-specified humidity range.
- Air changes (per hr): No data in final report but it did not deviate from the guideline-specified air change range.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 May, 2017 To: 15 June, 2017

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: The test article was moistened with distilled water to create a paste.
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal
- % coverage: 10% of body surface
- Type of wrap if used: Porous dressing and porous non-irritating tape.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes
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: Observations for mortality, toxicity and clinical signs were recorded at one and four hours postdosing and once daily thereafter for 14 days. Body weights were recorded pre-test, weekly and at termination.
- Necropsy of survivors performed: yes

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:
other: Immediately following unwrapping, erythema was absent to very slight and edema was absent. By Day 14, erythema edema were absent.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Chromorhinorrhea and wetness of the anogenital area were observed.
Body weight:
All ten animals gained body weight by study termination.
Gross pathology:
No abnormalities were observed upon necrospy.

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 2,000 mg/kg body weight.
Executive summary:

The dermal lethality potential of the test article was evaluated in male and female Sprague Dawley rats. The study was performed in compliance with OECD GLP regulations. The test was performed according to OECD 402. Rats (5 males and 5 females) received a 24-hour dermal exposure of 2000 mg/kg. The test article was moistened with distilled water on porous gauze and applied to the dorsal region (clipped, 10% body surface) of each rat. The exposure site was wrapped with porous dressing and porous non-irritating tape (semi-occlusive). After 24 hours the gauze was removed and any remaining test article was removed by washing with distilled water. All rats survived the study. Clinical observations included chromorhinorrhea and wetness of the anogenital area. Immediately following unwrapping, erythema was absent to very slight and edema was absent. By Day 14, erythema and edema were absent. Based on the results of the study, the rat dermal LD50 of the test article is greater than 2,000 mg/kg body weight.