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Description of key information

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 15000 mg/kg bw (25 % suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw. Similarly, a single application of 15000 mg test substance per kg bw did not cause lethality in male Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.  


The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines
Qualifier:
according to guideline
Guideline:
other: company guideline similar to OECD Guideline 401
Deviations:
no
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
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: Hoechst AG, breeding colony
- Weight at study initiation: 84 to 95 g
- Fasting period before study: 16 h
- Housing: grouped, plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, 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: 25 %
Doses:
15000 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 weighing: weekly
- Necropsy of survivors performed: yes
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animals died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
- no animal showed any clinical symptoms
- faeces was red-coloured
Body weight:
- body weight development was not impaired
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of 15000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 15000 mg/kg bw (25 % suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines
Qualifier:
according to guideline
Guideline:
other: company guideline similar to OECD Guideline 401
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %
Doses:
15000 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
Sex:
male
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animals died within the observation period
Conclusions:
Single application of 15000 mg test substance per kg bw did not cause lethality in male Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 15 000 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

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 October - 12 November 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed in accordance with OECD, but not according to GLP guidelines and the English test report was reconstructed by the test institute from the study raw data and the original Czech report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Farm VELAZ, monitoring quality
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 225-275 g
- Fasting period before study: not stated
- Housing: 5 animals per plastic breeding cage VELAZ T4
- Diet (e.g. ad libitum): ST 1 Bergman - standard pellet diet ad libitum, Mill Kocanda, Jesenice u Prahy, Czech Republic
- Water (e.g. ad libitum): dinking tap water ad libitum
- Acclimation period: minumum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 4x6 cm (shaved 24 hours before application)
- Type of wrap if used: application site was covered by mull, plastic foil and held in contact by plaster (strapping)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24-hour application period, the remains of the test substance were removed from the skin
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): water was used to moisten test substance
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was done after 30 min, 3 hours of the 1st day, in the moring and afternoon of the second day and thereafter daily for 14 days; body weights were recorded before application, atday 8 and before euthanasia of animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:
Statistics:
not relevant
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived the 14-day observation period.
Clinical signs:
No clinical signs were observed during the 14-day observation period.
Body weight:
Body weight developments were within the physiological range.
Gross pathology:
All animals were without gross morphological alterations.
Other findings:
none
Interpretation of results:
GHS criteria not met
Conclusions:
67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted

The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight.
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
11 October - 12 November 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was performed in accordance with OECD, but not according to GLP guidelines and the English test report was reconstructed by the test institute from the study raw data and the original Czech report.
Justification for type of information:
See rationale and justification for the analogue read-across approach for the registration of the nanoform of Pigment Red 002 (chapter 13).
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding Farm VELAZ, monitoring quality
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 225-275 g
- Fasting period before study: not stated
- Housing: 5 animals per plastic breeding cage VELAZ T4
- Diet (e.g. ad libitum): ST 1 Bergman - standard pellet diet ad libitum, Mill Kocanda, Jesenice u Prahy, Czech Republic
- Water (e.g. ad libitum): dinking tap water ad libitum
- Acclimation period: minumum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 4x6 cm (shaved 24 hours before application)
- Type of wrap if used: application site was covered by mull, plastic foil and held in contact by plaster (strapping)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24-hour application period, the remains of the test substance were removed from the skin
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): water was used to moisten test substance
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination was done after 30 min, 3 hours of the 1st day, in the moring and afternoon of the second day and thereafter daily for 14 days; body weights were recorded before application, atday 8 and before euthanasia of animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:
Statistics:
not relevant
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived the 14-day observation period.
Clinical signs:
No clinical signs were observed during the 14-day observation period.
Body weight:
Body weight developments were within the physiological range.
Gross pathology:
All animals were without gross morphological alterations.
Other findings:
none
Interpretation of results:
GHS criteria not met
Conclusions:
67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted

The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw

Additional information

Justification for classification or non-classification

No classification, as no adverse effects were observed.