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Toxicological information

Acute Toxicity: dermal

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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:
2012

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
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Purity: 99.4%
Impurities: Not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Inc., Frederick, MD
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 240-257 g, females: 175-200 g
- Housing: Individually housed in plastic solid bottom polycarbonate cages. Enrichment was placed in each cage. Corncob bedding was changed at least once per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 55-68%
- Air changes (per hr): at or above 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
distilled
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 10% of body surface
- Type of wrap if used: 4-ply gauze and Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing: Yes. Solution not specified
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes, 75% w/w

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 and weighing: Daily for clinical signs. Weighed on Days 0, 7 and 14 (termination)
- Necropsy of survivors performed: yes
Statistics:
Not applicable

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:
No mortality
Clinical signs:
Besides mechanical damage due to unwrapping of the dose site, all animals were active and healthy during the observation period.
Body weight:
All animals gained weight during the 14-day observation period
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:
Under the conditions of this study, the single dose acute dermal LD50 of the test substance is greater than 5,000 mg/kg of body weight in male and female rats.
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 according to OECD 402 and OPPTS 870.1200. One dose of 5000 mg/kg of body weight was moistened with distilled water and then applied 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 behavioral changes 1 and 5.5 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, appeared active and healthy and gained body weight during the study. Apart from mechanical damage due to unwrapping around the dose site of all rats between Days 1 and 3, there was no dermal irritation recorded for any animal over the 14-day observation period. 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 LD50of the test substance is greater than 5,000 mg/kg of body weight in male and female rats.