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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The acute oral LD50 for the test substance was determined to be ca. 3.0 mL/kg (ca. 3200 mg/kg) in rats.

The acute inhalation LD50 for the test substance as saturated atmosphere was determined to be > 1.14 mg/L in rats.

The acute LD50 after intraperitoneal application of the test substance was determined to be ca. 0.57 mL/kg (ca. 608 mg/kg) in mice.

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:
1967-09-26/27 and 1967-10-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Please refer to "Principles of method"
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
No specific details for test material were provided.
Species:
rat
Strain:
other: US
Sex:
male/female
Details on test animals or test system and environmental conditions:
No details were provided.
Route of administration:
oral: gavage
Vehicle:
other: water emulsion containing Traganth
Details on oral exposure:
- Application form: emulsion
- Concentration in vehicle: 2, 20 and 30 % (v/v)
Doses:
0.2, 1.6, 2.5 and 3.2 mL/kg bw
213.38, 1707.04, 2667.25 and 3414.08 mg/kg bw (calculated from mL/kg with a density of 1.0669 g/cm^3)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No statistical analysis was performed.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 200.7 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated from mL/kg with a density of 1.0669 g/cm^3
Mortality:
3.2 mL/kg bw: 6 animals died within 24 h after application. 1 animal died between 24 and 48 h after application.
2.5 mL/kg bw: 2 animals died within 48 h after application. 1 animal died between 48 h and 7 days after application.
1.6 mL/kg: 1 animal died between 48 h and 7 days after application.
No further mortality was observed.
Clinical signs:
3.2 mL/kg: ventral/side position, dyspnea, apathy, anesthetic like behavior, slack body tonus, striking blood flow in extremities, ears, nose and lips, secretion from nose. All symptoms lasted 2 days, gradually improved and were not detected in survivors from day 5 onward.
2500 cmm/kg: Belly/side position, difficult breathing and apathy was detected directly after application. After 24 h eyes were clotted and the nose was encrusted with blood. Symptoms lasted 1 day, gradually improved and were not detected in survivors from day 4 onward.
1.6 mL/kg: Staggering walk, increased breathing rate, pilo erection, hunched position, apathy was observed for over 1 day. After 2 days symptoms nearly disappeared.
0.2 cmm/kg: Staggering walk, increased breathing rate and pilo erection was observed for over 1 day. After 2 days symptoms nearly disappeared.
Body weight:
Body weights were only determined before treatment.
Gross pathology:
3.2 mL/kg: 1x blood encrusted nose, 1x chronic bronchitis
2.5 mL/kg: 2x blood encrusted nose, 1x dubiose fatty liver, 1x chronic bronchitis
No other observations were made in survivors or animals that died after treatment.
Other findings:
No other observations were made.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 200 mg/kg bw
Quality of whole database:
The study was conducted comparable to guideline with sufficient documentation.

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:
1967-09-25 to 1967-10-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Please refer to "Principles of method"
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
No specific details for test material were provided.
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No details were provided.
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Remark on MMAD/GSD:
No details were provided.
Details on inhalation exposure:
200 L air/ h were run through a 5 cm thick layer of the test substance. The atmosphere temperature was 20 °C. The atmosphere was saturated with vapour.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
1.14 mg/L = 263 ppm (calculated from the amount of test substance weight loss during exposure)
No. of animals per sex per dose:
2 runs with each 6 animals, no details on sex distribution were provided.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: No details on observation intervals provided. Animals were weighted before treatment and before sacrifice.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
1.14 mg/L air (nominal)
Based on:
test mat. (dissolved fraction)
Exp. duration:
8 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.14 mg/L air (nominal)
Based on:
test mat. (dissolved fraction)
Exp. duration:
8 h
Mortality:
No mortatity was observed.
Clinical signs:
other: No clinical signs were detected.
Body weight:
Mean body weight before treatment was 1225 g (1. group) and 1180 g (2. group).
Mean body weight after 7 days of observation was 1250 g (1. group) and 1300 g (2. group).
Gross pathology:
No changes were detected.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 140 mg/m³
Quality of whole database:
The study was conducted comparable to guideline with sufficient documentation.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity

 

Oral

A study was conducted similar to the OECD 401 guideline. The test substance was orally administered to male and female rats in an emulsion. Each 10 animals were treated with concentrations of 0.2, 1.6, 2.5 and 3.2 mL/kg. Afterwards the animals were observed for 7 days. Several clinical symptoms were observed in increasing intensity with increasing dose. During the observation period 7 animals died after receiving 3.2 mL/kg, 3 treated with 2.5 mL/kg and one animal treated with 1.6 mL/kg. Therefore a LD50 of ca. 3.0 mL/kg was determined which corresponds to a calculated concentration of ca. 3200 mg/kg based on test substance density.

 

Inhalation

A study was conducted similar to the OECD 403 guideline. 200 L air/ h were run through a 5 cm thick layer of the test substance at atmosphere temperature of 20 °C. The atmosphere was saturated with vapour and the calculated concentration, based on substance weight loss, was 1.14 mg/L air. 2 independent groups of each 6 rats were exposed for 8 h. Afterwards the animals were observed for 7 days. No mortality, clinical symptoms or pathological changes were detected. Therefore a LD50 of > 1.14 mg/L was determined for the saturated atmosphere. As the atmosphere was saturated, no concentration exceeding the evaluated test substance concentration will be reached and no further effects will be expected, therefore the test substance does not need to be classified.

 

Intraperitoneal application

A non-guideline study was conducted in mice. The test substance was administered intraperitoneal in concentrations of 0.2, 0.4, 0.5, 0.64, 0.8 and 1.6 mL/kg to 10 mice each. Afterwards the animals were observed for 7 days. Several clinical symptoms were observed. During the observation period 10 animals died after receiving 1.6 and 0.8 mL/kg and 9 after 0.64 mL/kg. Therefore a LD50 of ca. 0.57 mL/kg was determined which corresponds to a calculated concentration of ca. 608 mg/kg based on test substance density.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218. As a result the substance is considered to be not classified for acute oral and inhalation toxicity.