Registration Dossier

Administrative data

Description of key information

Acute oral toxicity > 2000 mg/kg bw (OECD 423); acute dermal toxicity > 2000 mg/kg bw (OECD 402), acute inhalation toxicity no data.

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
Study period:
2009-06-16 to 2009-06-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%
Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Orient Bio Ltd, 143-1 Sangdaewon-dong, Jungwun-Gu, Seoungnam-Si, Gyeonggi-Do, South Korea
- Age at study initiation: 7-8 wks
- Weight at study initiation: 179.1 to 227.5 g
- Fasting period before study: Yes, overnight
- Housing: 3-4 animals per stainless steel wire cage (255 width x 465 mm length x 200 mm height)
- Diet: Ad libitum pellet chow
- Water: Ad libitum
- Acclimation period: 5-15 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19~25 °C
- Humidity: 30~70 %
- Air changes: 10~20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg bw as recommended by OECD Guideline 423, with the next dose determined as per the flow chart in the guidance following a 2 d observation period after treatment.

Doses:
300 mg/kg bw, 2000 mg/kg bw
No. of animals per sex per dose:
6 females per dose (0 males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations on days 0, 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross findings.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Liquid faeces in 1/6 rats at 300 mg/kg bw dose level 1 hr after dosing; soft faeces in 2/6 rats at 2000 mg/kg bw dose level 1 hr after dosing. These were considered to be due to chance, rather than be associated with the test item because they occurred at a low incidence.
Body weight:
No treatment-related effects (for full results please refer to attached supporting information).
Gross pathology:
No treatment-related effects.
Interpretation of results:
other: not classified
Conclusions:
The test substance was assessed for acute oral toxicity according to OECD Guideline 423. The LD50 of the test material, DEHCH was >2,000 mg/kg bw in female rats. The substance is therefore not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Guideline study, GLP study

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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
Study period:
2010-04-28 to 2010-05-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Batch No.: 20091203
Purity: 99.42%
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd, Oxfordshire, United Kingdom
- Age at study initiation: 8-12 wks
- Weight at study initiation: ≥ 200 g
- Fasting period before study:
- Housing: Individually during 24 hr exposure period; in groups of 4 for remainder of study
- Diet: Ad libitum, 2014 Teklad Global Rodent diet.
- Water: Ad libitum, mains water
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C to 25 °C
- Humidity: 30 % to 70 %
- Air changes: ≥ 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: Approx. 10 % of total body surface area
- Type of wrap if used: Surgical gauze held in place with semiocclusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Volume applied: 2.11 mL/kg bw
- Constant volume or concentration used: no
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Preliminary study: 1 male, 1 female at 2000 mg/kg bw
Main study: 4 male, 4 female at 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 30 min, 1, 2 and 4 hrs after dosing
- Necropsy of survivors was performed
- Other examinations performed: clinical signs, body weight, organ weights.
Preliminary study:
Mortality 0/2 animals.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the observation period
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected bodyweight gains during the study period. For full results please refer to attached supporting material.
Gross pathology:
No abnormalities were detected during necropsy.
Other findings:
- There were no signs of skin irritation or corrosion.
Interpretation of results:
not classified
Conclusions:
The test substance was assessed for acute dermal toxicity according to OECD Guideline 402. The LD50 of the test material was >2000 mg/kg bw. The substance is therefore not classified.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Guideline study, GLP study

Additional information

Acute oral toxicity

In study No. G09073, the acute oral toxicity to rats was tested. There was no mortality or other signs of systemic toxicity up to a dose of 2000 mg./kg bw. It can therefore be concluded that the LD₅₀ is > 2000 mg/kg bw.

Acute inhalation toxicity

No data were available for acute inhalation toxicity. However, given the extremely low vapour pressure of the substance, and the lack of toxic effects seen in the acute oral and acute dermal toxicity substances, this is not a concern.

Acute dermal toxicity

In Harlan study No. 3058/002, the acute dermal toxicity to rats was tested. There was no mortality or other signs of systemic toxicty up to a dose of 2000 mg/kg bw. It can therefore be concluded that the LD₅₀ is > 2000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

According to Regulation (EC) 1272/2008, substances should be classified if they have acute oral LD₅₀ values of ≤ 2000 mg/kg bw. The LD₅₀ is above this value, so the substance should not be classified.

Acute dermal toxicity

According to Regulation (EC) 1272/2008, substances should be classified if they have acute dermal LD₅₀ values of ≤ 2000 mg/kg bw. The LD₅₀ is above this value, so the substance should not be classified.

Acute inhalation toxicity

Due to lack of data, the toxicity should be classified as "data lacking", even though inhalation toxicity is not of concern.