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Description of key information


The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw 



  

after single, oral gavage in the 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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study, no GLP, short report.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF-Zucht: Firma Gassner, Ottobrunn, Deutschland
- Age at study initiation: no data
- Weight at study initiation: male: ca 215 g; female: ca. 155 g
- Fasting period before study: no data

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS : no data
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 or 16 % (w/v; suspension)
- Amount of vehicle (if gavage): max. ca. 8,6 mL
- Justification for choice of vehicle: the test material is insoluble in all possible vehicles
- Lot/batch no. (if required): no data


MAXIMUM DOSE VOLUME APPLIED: ca. 8,6 mL
Doses:
200 - 1600 - 3200 - 6400 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 6 400 mg/kg bw
Based on:
test mat.
Mortality:
One male rat died about 7 days after treatment. The animal showed pneumonia during necropsy. The death was not considered as a consequence of treatment. Surviving animals also showed signs of pneumonia at necropsy.
Clinical signs:
other: Dyspnea and apathy were observed for 2 to 5 days.
Gross pathology:
The deceased animal showed pneumonia during necropsy. Surviving animals also showed signs of pneumonia at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat.
Executive summary:

The acute oral toxicity of the test material was determined in Sprague-Dawley rats. The test material was suspended in an aqueous suspension of carboxymethyl-cellulose at 2 % (low dose) or 16 % (w/v; other doses). Doses employed were 200, 1600, 3200 and 6400 mg/kg applied orally by gavage.

The aproximate mean lethal dose (AID 50) was above 6400 rng/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 400 mg/kg bw
Quality of whole database:
reliable with restrictions (2), ealry study predates GLP,

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early sudy, no GLP, outdated methodology, limited report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
only 1 hour exposure
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: MUS-RATTUS AG, Brunnthal, Germany
- Age at study initiation: no data
- Weight at study initiation: male: ca 315 g; female: ca. 217 g
- Fasting period before study: no data

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data
Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: ambient air at 1 m³/h
- Method of conditioning air: no data
- System of generating particulates/aerosols: according to B. M. Wright (J.Scient. lnstrum. 27, 12 (1950): "A New Dust Feed Mechanism")
- Method of particle size determination: none
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE
- Brief description of analytical method used: no data, concentrations were calculated
- Samples taken from breathing zone: no data

VEHICLE
- Composition of vehicle (if applicable): ambient air
- Concentration of test material in vehicle (if applicable): ca 4 mg/L

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 1 h
Concentrations:
calculated as ca. 4 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 4 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
none
Clinical signs:
other: none
Body weight:
no data
Gross pathology:
no adverse findings
Other findings:
none
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The minimum lethal concentration after 1 hour of whole body inhalation was above 4 mg/kb bw.
Executive summary:

The inhalation toxicity of the test material was determined in rats. Animals were exposed for 1 hour to a concentration of ca. 4 mg/L (whole body, technical maximum concentration). No adverse effects on general condition nor mortality were observed. At necropsy no effects of the test material were detected.

The mean lethal dose was above 4 mg/L in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
4 mg/m³ air
Quality of whole database:
reliable with restriction (early study, predates GLP, non-standard design)

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP; short report
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: white Wiener
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BASF, Ludwigshafen, Germany
- Age at study initiation: no data
- Weight at study initiation: ca. 2,8 kg (mean)


- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 340 cm²
- Type of wrap if used: paper and textile

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration: 30 % (paste)
- Constant concentration used: yes
- For solids, paste formed: yes

VEHICLE
Olive oil
- Amount(s) applied (volume): ca 4 mL in treated and 8-9 mL in control

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
male treaded: 4
female treaded: 2
male untreaded: 1
female untreaded: 1
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; other: local irritation effects
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1 male animal died 10 days after treatment.
Clinical signs:
other: Temporary diarrhea, severe local blue discoloration by the test material. One male showed reduced food uptake and degraded general condition before it died after 10 days. No findings in control animals.
Gross pathology:
Moderately reduced to completely missing perirenal fatty tissue.
In one animal perirenal fatty tissue was well developed with blue discoloration.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.
Executive summary:

The acute dermal toxicity of the test material was determined in six rabbits. The material was applied at a dose os 2000 mg/kg bw (limit test) at a concentration of 30 % in olive oil und semiocclusive conditions for 24 hours. Animals developed temporary diarrhea and severe blue discoloration by the test material on the first day. One male animal died after ten days after showing reduced general condition and food uptake.

Controls did not show any effects.

The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
reliable with restrictions (2), ealry study predates GLP, rabbit study

Additional information

The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat.

The inhalation toxicity of the test material was determined in rats. Animals were exposed for 1 hour to a concentration of ca. 4 mg/L (whole body, technical maximum concentration). No adverse effects on general condition nor mortality were observed. At necropsy no effects of the test material were detected. The mean lethal concentration was above 4 mg/L in rats.

The acute dermal toxicity of the test material was determined in six rabbits. The material was applied at a dose os 2000 mg/kg bw (limit test) at a concentration of 30 % in olive oil und semiocclusive conditions for 24 hours. Animals developed temporary diarrhea and severe blue discoloration by the test material on the first day. One male animal died after ten days after showing reduced general condition and food uptake.

Controls did not show any effects.

The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.


Justification for selection of acute toxicity – oral endpoint
only available study

Justification for selection of acute toxicity – inhalation endpoint
only available study

Justification for selection of acute toxicity – dermal endpoint
only available study

Justification for classification or non-classification

not classified;

The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat. No adverse finding were recorded after inhalation of the maximum achievable concentration for 1 hour.

After dermal application the LD50 was greater than 2000 mg/kg bw in rabbits.