Registration Dossier

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:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nouan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Purity: 92.1%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 weeks
- Weight at study initiation: males 250-261 g and females 179-193 g
- Fasting period before study: No
- Housing: individually housed in plastic solid bottom polycarbonate cages
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum.
- Water: Filtered tap water was supplied ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22ºC
- Humidity (%): 30-67%
- Air changes (per hr): 14
- Photoperiod: 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Details on dermal exposure:
TEST SITE
- Area of exposure: the test substance was applied to a 2-inch x 3-inch, 4-ply gauze pad and placed on a dose area of approximately 2 inches x 3 inches
- % coverage: approximately 10% of the body surface
- Type of wrap if used: covered with a 2-inch x 3-inch, 4-ply gauze pad, wrapped with 3-inch Durapore tape

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
5000 mg/kg
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: The animals were observed for mortality, signs of gross toxicity, and behavioural changes 1 and 4 hours after application and at least once daily thereafter for 14 days.
- Frequency of weighing: prior to test substance application (initial) and again on Days 7 and 14 (termination)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
There were no signs of gross toxicity, dermal irritation, or abnormal behaviour.
Body weight:
All animals survived, gained body weight, and appeared active and healthy during the study.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application. Five thousand milligrams of the test substance per kilogram of body weight was applied to a patch and then to the skin of ten healthy rats (five male and five female) for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioural changes 1 and 4 hours post-dosing and at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.

All animals survived, gained body weight, and appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, or abnormal behaviour. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5000 mg/kg of body weight in male and female rats.