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Administrative data

Description of key information

Acute oral toxicity in rats: LD50 > 10000 mg/kg bw.
Acute dermal toxicity in rats: LD50 > 2000 mg/kg bw.

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:
05. Sept. 1986 - 19. Sept. 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report, which meets basic scientific priniciples
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: WISW (SPF TNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann, Borchen, Germany
- Weight at study initiation: 115.4 g
- Housing: 1-5 animals per macrolon cage type III
- Diet (e.g. ad libitum): R10 Alleindiät, Ssniff Spezialfutter GmbH, Soest Germany; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimatisation: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 12.5 cm3/kg
Doses:
10000 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
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
1-2 hours after dosing bristled coat and diuresis were recorded in all animals. After 4-6 hours all animals showed oily wet coat in the anal region and on the hind legs.24 hours after administration all animals were free of symptoms.
Body weight:
no effect on body weight
Gross pathology:
Necropsy revealed no macroscopic changes.
Other findings:
None

 

 

 

 

 

 

 

 

6 hours

24 hours

7 days

14 days

Mortality

female

0/5

0/5

0/5

0/5

 

male

0/5

0/5

0/5

0/5

 

 

 

 

 

 

0/5 = animals dead/animals treated

Interpretation of results:
GHS criteria not met
Conclusions:
Under the described test conditions, mortality did not occur up to the highest dose tested of 10000 mg/kg/bw. Thus, the LD50 is above 10000 mg/kg/bw, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Executive summary:

Tetrabutan (dest.) was tested in an Acute Oral Toxicity Test, performed in consideration of the guideline OECD 401. The test was conducted as a limit test. 5 female and 5 male rats were administered Tetrabutan (dest.) at a dose of 10000 mg/kg bw by gavage. Besides transient clinical symptoms attributable to an overload with test substance, no mortality or irreversible clinical signs were recorded. Tetrabutan (dest.) is practically non toxic by the oral route. The LD50 > 10000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

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
Study period:
14 January 2010 to 3 February 2010 (in-life phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute dermal toxicity (2-1-2), 12 Nohsan No 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 228 to 334 g
- Fasting period before study: none
- Housing: idividually in solid bottomed polycarbonate cages with a stainless steel mesh lid
- 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 (%): 40-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 14 January 2010 (animal allocation) To: 3 February 2010 (terminal necropsy)
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region (approximately 50 mm x 50 mm)
- % coverage: 10% of total body surface area
- Type of wrap if used: porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30 - 40°C)
- Time after start of exposure: 24 hrs.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.532 ml/kg bodyweight
- Constant volume or concentration used: test material used as supplied (SG 0.79 g/ml)

Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5 male and 5 female animals
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). Local dermal irritation at the treatment site was assessed daily. The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
Not undertaken
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0/5 males and 0/5 females
Clinical signs:
There were no clinical signs considered to be related to treatment.
Very slight erythema was observed in one male and three females from Day 2, this sign had resolved in all animals by Day 4. In addition, desquamation (exfoliation) was observed in three males and three females from Day 4 to 6, resolving completely in all animals by Day 8.
Scabbing was also observed in two males from Day 7 or 8, resolving in one animal by Day
12 and persisted in the other until Day 15.
Body weight:
One female (Animal No. B7) was considered to have a low bodyweight gain Days 8 to 15.
All other animals were considered to have achieved satisfactory bodyweight gains throughout
the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute median lethal dermal dose (LD50) to rats of Tetrabutane was demonstrated to be greater than 2000 mg/kg bodyweight. Thus, the LD50 is above 2000 mg/kg/bw, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Executive summary:

A study was performed at the Laboratories of Huntingdon Life Sciences, Alconbury, on behalf of Evonik Oxeno GmbH. , to assess the acute dermal toxicity of the test substance Tetrabutane. The study was conducted to GLP and in accordance with OECD Guideline 402 and EU Method B.3. The test substance was administered to the clipped dorsal skin of 5 male and 5 female rats at a dosage of 2000 mg/kg bodyweight under occlusive dressings for 24 hours (Limit test). Systemic and local signs of reaction to treatment were recorded at least once daily for 14 days following removal of the dressings.  There were no deaths and no systemic signs of reaction to treatment. Transient very slight erythema was observed at the application sites of one male and three females from Day 2 to 4 and desquamation (exfoliation) in three males and three females from Day 4 to 7, followed by scabbing in two of the males up to Days 12 or 15. One female rat was considered to have low bodyweight gain from Day 8 to 14.

The acute dermal median lethal dosage (LD50) to rats of Tetrabutane was demonstrated to be greater than 2000 mg/kg bodyweight.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

Tetrabutane (dest.) was tested in an acute oral toxicity study, performed in consideration of the guideline OECD 401. Five male and five female rats were administered Tetrabutane (dest.) by oral gavage at a dosage of 10000 mg/kg bw.(Limit test). Besides transient clinical symptoms attributable to an overload with test substance, no mortality or irreversible clinical signs were recorded. The acute oral LD50 of Tetrabutan is greater than 10000 mg/kg bw.

Supporting data on the structurally related source substances Oxooil LS9 and Oxooil LS13 show similarly low toxicity.

 

Acute dermal toxicity

Tetrabutane (technical) was tested in an acute dermal toxicity study in rats, in accordance with test guideline OECD 402. The test substance was administered to the clipped dorsal skin of 5 male and 5 female rats at a dosage of 2000 mg/kg bodyweight under occlusive dressings for 24 hours (Limit test).  There were no deaths and no systemic signs of reaction to treatment. Transient very slight erythema and/or desquamation (exfoliation) were observed at the application sites of three male and three female rats up to Day 7, followed by scabbing in two of the males up to Days 12 or 15. One female rat was considered to have low bodyweight gain from Day 8 to 14. However, this is not uncommon for female rats of this age and strain and is not considered to be toxicologically significant. The acute dermal LD50 of Tetrabutane is greater than 2000 mg/kg bw..

 

Acute inhalation toxicity

It was not considered necessary to undertake an acute inhalation toxicity study with Tetrabutane, as it has a low vapour pressure (< 1 hPa at 20°C) and a high boiling point (278 °C at 1013 hPa), and would be expected to result in only minimal inhalation exposure. In addition, the acute toxicity of Tetrabutane is low by both the oral and dermal routes of exposure.

 

 

Justification for classification or non-classification

No classification for acute toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.

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