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Administrative data

Description of key information

Acute Toxicity, Oral, 1 key study, LD50>5000mg/kg for rat (equivalent or simlar to OECD TG 401)
Acute Toxicity, Inhalation-No testing required based on Column 2 Annex VIII.
Acute Toxicity, Dermal 1 key study, LD50>2000mg/kg for rabbit (equivalent or simlar to OECD TG 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report. Performed in a manner equivalent or similar to OECD Method 401. GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female young adult Sprague-Dawley rats obtained from Taconic Farms (Germantown) NY were used in this study. The body weights ranged from 239-533 grams for the males and 182-321 grams for the females. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 70-73F with a relative humidity of 27-74%
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were fasted overnight and dosed via oral gavage. Body weights were recorded prior to fasting and on Days 0,7, and 14. Food was returned to each animal immediately after dosing
Doses:
5.0 gm/kg
No. of animals per sex per dose:
5 male and 5 females
Control animals:
no
Details on study design:
Signs of toxicity were recorded at approximately 0.5, 1 and 4 hours after test substance administration and daily thereafter with the exception of weekends and holidays. The condition of each animal (live, dead, moribund) was checked once daily. All animals were necropsied at the termination (day 14) of the study.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths
Clinical signs:
The following clinical observations were noted in one or more of the animals: soft stool, urogenital discharge, and anal discharge.
Body weight:
there was an increase in mean body weights and individual body weights during the study in relation to the prefast body weights.
Gross pathology:
No changes noted during necropsy that could be related to treatment
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the parameters of this study, the acute oral LD50 for the submission substance is >5.0 g/kg in the rat. This finding does not warrant the classification as an acute oral toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

In this study, ten rats were given a single 5.0 g/kg dose of the test material by oral gavage. The rats were then observed for 14 days and a gross examination was performed at the termination of the study period. All animals survived to termination of the study period. There was an increase in mean and individual body weights in relation to the pre-fast body weights. The following clinical observations were noted in one or more of the animals: soft stool, urogenital discharge, and anal discharge. There were no treatment-related gross pathological changes. Based on the parameters of this study, the acute oral LD50 for the test material is >5.0 g/kg in the rat. This finding does not warrant the classification of the test material as an acute oral toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 402. GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Male and female young adult New Zealand White rabbits obtained from Hazleton Research Products, Inc. (Denver, Pa) were used in this study. The male body weights ranged from 2.2-2.8 kilograms and the female body weights ranged from 2.2-2.7 kilograms. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 68-72F with a relative humidity of 41-61%.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The back of each animal was shaved prior to administration of the test substance. T he dose was applied evenly to the back of each animal followed by a layer of 8-ply gauze to cover the test site. The gauze was covered by a rubber dam and the anterior and posterior edges of the dam securely taped. A plastic Elizabethan collar was placed on each animal to prevent oral ingestion of the test substance and mechanical irritation of the test site.
Duration of exposure:
24h
Doses:
2gm/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
Following a 24 hour exposure period, the dam and gauze were removed and the residual test substance wiped from the site. Clinical observations were recorded at approximately 1 and 4 hours after test substance administration and daily thereafter except on weekends. The condition of each animal (live, dead, moribund) was checked at least once daily. T he study was terminated after 14 days and each animal necropsied.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
The following clinical obsrvations were noted in one or more animals: soft stool, decreased fecal output, diarrhea, decreased urinary output, and decreased food consumption.
Body weight:
There was an increase in mean and individual body weights during the study in relation to the Day 0 body weights with the exception of one male that lost 300 grams between days 7 and 14. This animal had diarrhea during the period of weight loss.
Gross pathology:
There were no gross pathological findings noted at necropsy that could be related to treatment
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for acute dermal toxicity of the submission substance is greater than 2000 mg/kg bw in the New Zealand White rabbit. This finding does not warrant classification of the test material as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The test article was administered as a single dose for 24 hours to ten white rabbits at a concentration of 2000 mg/kg to assess acute dermal toxicity. Animals were observed for fourteen days following exposure. All animals survived to the termination of the study period. An increase in mean and individual body weights was observed during the study with the exception of one male that lost weight between days 7 adn 14. Soft stool, decreased fecal output, diarrhea, decreased urinary output and decreased food consumption were noted in one or more animals. There were no treatment-related gross pathological changes. Based on the conditions of this study, the dermal LD50 for the test material is greater than 2.0 gm/kg. This finding does not warrant classification of the test material as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50

Additional information

There are adequate data for the assessment of the acute toxicity of the submission substance. All animal studies were performed in a manner similar or equivalent to currently established OECD test guidelines. The submission substance has a low order of toxicity via ingestion where the LD50 in rats is >5000mg/kg and via dermal exposure where the LD50 in rabbits is >2000mg/kg. It is not required to dose via the inhalation route since exposure via inhalation is unlikely taking into account the physical chemical properties of the substance. Based on these data, the acute toxicity of the submission substance is expected to be low.

Justification for classification or non-classification

The submission substance has a low order of acute toxicity where the LD50 via ingestion is > 5000 mg/kg and the LD50 via dermal exposure is >2000 mg/kg. Based on these data, classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.