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Administrative data

Description of key information

Single application of 5000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.

Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 26 MAY 1981 to 09 JUN 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in-house breeding colony
- Weight at study initiation:168 - 179 g
- Fasting period before study: 16 h before dosing, 2 h after
- Housing: in groups
- Diet: ALTROMIN 1324 (Altroge, Lage, Germany). ad libitum
- Water: tap water, ad libitum
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5 % suspension in sesame oil
Doses:
5 000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes
Other findings:
The following effects were observed after administration of test substance: hair raising, diarrhea, yellow coloured faeces. 72 h after application animals were free of any symtoms.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of 5000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.
Executive summary:

Female Wistar rats were subjected to test acute oral toxicity. 5000 mg/kg bw of the test substance were administered by gavage. No animal died under these conditions during the 14 -day observation period, thus leading to a LD50 > 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Acetolone Pigments – Nanoforms and Bulk Forms (Chapter 13)
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
reliable with restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 5 May 1981 to 19 MAY 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Relevant methodological deficiencies
Qualifier:
according to guideline
Guideline:
other: Company guideline
Deviations:
no
Principles of method if other than guideline:
test for acute toxicity after inhalation exposure (dust exposure in open, dynamic system)
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation
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: own breed
- Weight at study initiation: males: mean 199 g (range: 196 to 201 g); females: mean 205 g (range: 195 to 216 g)
- Housing: plastic cages
- Diet: Standard husbandry diet Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 °C (in exposure cylinder)
- other measurmenst during dust exposure: 21% oxygen, 5000 ppm carbon dioxid, no carbon monoxide
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindrical plastic cage
- Exposure chamber volume: 60 L
- Method of holding animals in test chamber: each animal was in a plastic tube
- Source and rate of air: laminar air stream of 900 L/hour at 1 bar from above
- System of generating particulates/aerosols: dustgenerator "Wright Dust Feed Mechanism" of L. Adams Ltd., London, UK
- Treatment of exhaust air: exhaust device at the basement of the exposure chamber in line with a diverse system of filters

TEST ATMOSPHERE ANALYSIS
- Brief description of analytical method used: gravimetric measurement: The test atmosphere was sucked through filters ("Experimentiertrommelgasfilter", Elster AG, Mainz-Kastel, Germany; as well as a fibre glass and a membrane filter (diameter of pores 0.65 µm) Sartorius Membranfilter GmbH, Göttingen, Germany) by means of vacuum (at 1200 L/h). The exhaust quantity was 10 L/min. The filters were positioned in an exsiccator 24 h before use. The filters were weighed before and after each measurement by means of electrical scales (Sartorius-Werke GmbH, Göttingen, Germany).
- Waste treatment: After the filters 2 washing bottles, filled with water and polyglycol 400, were placed. Dust leaving the test chanmber due to high pressure was sucked into a gas cleaning station.

TEST ATMOSPHERE
- Particle size distribution: > 0.65 µm
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric measurement
Duration of exposure:
4 h
Concentrations:
mean: 1274 mg/cubic metre air
range: 521 to 2511 mg/cubic metre air
Concentration applied was the maximum technically feasible concentration.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily except on weekends
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 274 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: maximum feasible concentration tested; no animals died within the 14 day observation period

- no deaths occurred

- during dust exposure rats showed unsteady breathing

- behaviour of the rats was normal during the 14 days observation period

- body weight development was normal during the 14 days observation period

- no gross organ changes were seen at necropsy

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. Mean dust exposure concentration was 1274 mg test substance per cubic metre (i.e. maximum technically feasible concentration; exposure ranged from 521 to 2511 mg/ cubic metre). The rats were exposed for 4 hours, nose only. All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 1274 mg/m³ for the inhalation of dust.

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Acetolone Pigments – Nanoforms and Bulk Forms (Chapter 13)
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 1 274 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Acetolone Pigments – Nanoforms and Bulk Forms (Chapter 13)
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 1 274 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 274 mg/m³
Quality of whole database:
reliable with restrictions

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

No classification: No adverse effects observed