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Administrative data

Description of key information

Oral: LD50 > 3341 mg/kg  (rat).
Inhalation: No mortalitiy after an 8-hour inhalation of an an atmosphere highly enriched with vapors of the test substance.
Dermal: LD50 > 2000 mg/kg (rat).

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:
27.09.1972 - 03.10.1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, acceptable for assessment
Principles of method if other than guideline:
BASF test
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage with an aqueous solution of the test substance.
The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 255 (225-283) g males; 185 (154-204) g females
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2-30%
- Amount of vehicle: 1.54 - 5.55 cm3/animal
Doses:
232, 1856, 3712 and 7424 mg/kg b.w. (= approx. 200, 1600, 3200, 6400 mm3/kg; density of the 45% solution = 1.16 mg/mm3; density of the pure TS = 1.36 mg/mm3 )
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observations for clinical signs; weighing only prior to application
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 424 mg/kg bw
Remarks on result:
other: Calculated for a concentration of 100% test substance, the LD50 is > 3341 mg/kg b.w.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 7 424 mg/kg bw
Remarks on result:
other: Calculated for a concentration of 100% test substance, the LD0 is >= 3341 mg/kg b.w.
Mortality:
not reported
Clinical signs:
other: not reported
Gross pathology:
nothing abnormal found
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23. - 31.08.1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, acceptable for assessment
Principles of method if other than guideline:
BASF test
The inhalation risk test (IRT) was performed in principle as described in OECD Guideline 403. The aim of the test was to demonstrate the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at a temperature chosen for vapor generation (i.e. 20 °C for the present test substance).
The animals were exposed to the test substance for 8 hours (flow-through, 200 liters/hour). The treatment was followed by an observation period of 7 days.
GLP compliance:
no
Test type:
other: IHT (Inhalation hazard test)
Species:
rat
Strain:
other: Siv
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation: 552-566 g males; 518-530 g females
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Rate of air: 200 l
- Method of conditioning air: Vapours were generated by bubbling air through a column of about 5 cm above a fritted glass disc in a glass cylinder.
- Temperature air chamber: 20°C


TEST ATMOSPHERE
- Brief description of analytical method used: Inhalation hazard test
- Samples taken from breathing zone: no
Analytical verification of test atmosphere concentrations:
no
Remarks:
The nominal concentration can be calculated as quotient of the amount of test substance weight loss during the exposure and the amount of air used during the exposure.
Duration of exposure:
8 h
Concentrations:
6.925 (6.913-6.938) mg/l
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- The test was performed in two trials on two consecutive days under identical conditions with 6 animals per trial
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observations for clinical signs; weighing prior to application and at the end of the observation period
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 9.93 mg/L air
Exp. duration:
8 h
Remarks on result:
other: No mortality due to exposition to test substance vapour within 8 hours.
Mortality:
not observed
Clinical signs:
other: At the start of the test (not explained in detail), partly bloody secretion of eyes and noses, aqueous secretion of the eyes, evident irritation of noses and eyes and accelerated thoracic respiration were observed.
Body weight:
body weight gain: males 63-65 g; females 70-71 g
Gross pathology:
nothing abnormal detected

Negative Control: all 6 animals survived the exposition of 8 hrs to air and the observation period of 7 d. No clinical signs and gross abnormalities were observed.

Conclusions:
Irritating effects on mucous membrans.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River WIGa GmbH, Sulzfeld, Germany
- Age at study initiation: male 8 weeks; female 12 weeks
- Housing: single housing
- Diet (e.g. ad libitum): VRF 1(P); SDS Special Diets Services (Altrip) Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 20 - 80 %
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: about 40 cm²
- % coverage: 10


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


Duration of exposure:
24 hours
Doses:
2000 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
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
other: No systemic clinical sings were observed during clinical examination
Gross pathology:
No abnormalities were noted.
Other findings:
Local effects:
Slightly yellowish discoloration of the application site was observed on study day 1 until study day 9 in all animals after application.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral:

Several studies suggest that the test substance is of low acute toxicity after oral administration:

In the key study, the acute oral toxcity of a product containing 45 % test substance in water (Fixapret CPN) was tested in rats. The oral LD50 was > 6400 µl/kg, which corresponds to > 3341 mg/kg bw (100% substance) (BASF AG, 1973). There were no

signs of toxicity.

In two other studies, the oral LD50 values were above 10000 mg/kg bw (100% substance) in rats and mice, respectively (IRDC, 1983 a + b).

 

Dermal:

In a acute dermal toxicity study in rats according to OECD TG 402 in compliance with GLP a LD50 of > 2000 mg/kg was determined (BASF SE, 2009).

 

Inhalation:

In an inhalation risk test, the inhalation exposure for 8 h to an atmosphere enriched with vapors from a 45% aqueous solution of the test substance (Fixapret CPN, conc. 6.93 mg/L) at 20°C caused no mortality or adverse systemic effects in rats but some signs of dyspnea and irritation of mucous membranes (BASF AG, 1973). The low acute inhalation toxicity of the test substance is supported by the results of an acute inhalation toxicity study in rats, where no mortality was observed after a 4-hour exposure of rats to an aerosol of the test substance (IRDC, 1981). In this study, the LC50 for 100% neat substance was determined to be > 3.1 mg/L. In contrast, vapors generated at 150°C produced severe irritations and dyspnea and were lethal to rats within a few hours (BASF AG, 1973). Spot-like hyperemia and edemas of the lung were prominent, while hydrothorax was seen in isolated cases. This study is considered to be not valid for assessment since it is assumed that decomposition products of the test substance arising at temperatures greater than 40°C induced these serious effects (OECD SIDS, 2002).

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

no classification warranted