Registration Dossier

Administrative data

Description of key information

Oral LD50 values for Pigment Yellow 83 are > 2000 mg/kg bw, the limit for classification (LD50 (key study) > 15,000 mg/kg bw).

No lethality was observed after acute inhalation exposure to the maximum technically feasible test concentration of 4.4 mg/L Pigment Yellow 13 (strucutral analogue) and 0.23 mg/L Pigment Yellow 17 (strucutral analogue).

No lethality was observed after single dermal application of 1710 mg/kg bw Pigment Yellow 13 (strucutral analogue).

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 16 MAR 1977 to 30 MAR 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
study performed before 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
- Strain: WISKf (SPF 71), SPF breeding colony
- Weight at study initiation: mean 103 g
- Fasting period before study: 16 h
- Housing: 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% suspension in vehicle

MAXIMUM DOSE VOLUME APPLIED: 6.6 ml

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
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Mortality:
- no deaths occured
Clinical signs:
- after application the tested animals showed accelerated respiration and ruffled fur
- after application some animals remained in a crouched posture
- faeces was yellow-coloured in all animals
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: other: CLP regulation
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 the maximal applicable dose of 15000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw.

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.

.

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 jusitfication document in Chapter 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
reliable

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:
supporting study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
: 10 hrs light cycle, some exposure data are missing (e.g. MMAD (not calculated), equilibration period)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house breeding, SPF breeding colony
- Weight at study initiation: 170 - 190 g
- Housing: in Macrolon cages (type 4) in groups of 10, males and females separated
- Diet: NAFAG (Gossau SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1
- Humidity (%): 55+/-5
- Photoperiod: 10 hrs light cycle day
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation cylinder
- Method of holding animals in test chamber: seperate PVC tubes
- System of generating aerosols: Injecting the solid material with the help of "Grafix Exactometer injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: gravimetrically
- Temperature, humidity, oxygen: 24 °C, 38%, 20 Vol.%

TEST ATMOSPHERE
- Brief description of analytical method used: Concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 17.5 L/min.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: < 1 µm to > 7 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated
Analytical verification of test atmosphere concentrations:
yes
Remarks:
: gravimetric measurement
Duration of exposure:
4 h
Concentrations:
4250 (+/-128) mg/m³
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 250 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no death occurred
Clinical signs:
other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 4 DEC 1989 to 18 DEC 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
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: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males mean: 227 g; females mean: 195 g
- Housing: macrolon cages (type 4) groups of 5 respectively 2 (= control animal and animal killed 1 day post application)
- Diet: rat diet Altromin 1324 ( Altromin-GmbH, Lage/Lippe, Germany); ad libitum
- Water: Tap water; ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12


Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
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 1000 L/hour at 4 bar from above
- System of generating particulates/aerosols: dustgenerator "Wright Dust Feed" of L. Adams Ltd., London, UK
- Method of particle size determination: "Anderson-Kaskadenimpaktor Mark III" of Anderson Samples Inc, Atlanta, USA
- 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) Satorius Membranfilter GmbH, Göttingen, Germany) by means of vacuum. The exhaust quantity was 3 L/min, which resulted in an air flow of 1.25 m/sec. 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.

TEST ATMOSPHERE
- Particle size distribution: < 0.6 µm to > 10.3 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.0 - 1.1/ 2.3 - 2.8
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric measurement
Duration of exposure:
4 h
Concentrations:
230 mg/m³ air
No. of animals per sex per dose:
6/sex/treatment group
1/sex/control group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

- Control urine and blood samples were collected from control animals.
- On day 1, 2 and 7 one male and one female were sacrificed to obtain blood samples. Final sacrifice of the remaining 3 animals/sex was on day 14 of the observation period.
- Urin samples were collected starting on the day of exposure till day 7 of the observation period and the last night before sacrifice.
- To collect urine the rats were placed in metabolism cages overnight without witdrawal of food and water. For technical reasons urine was collected continously on day 6 and 7.
- Blood was collected via puncture of the retro-orbital plexus.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 230 mg/m³ air
Exp. duration:
4 h
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no deaths occurred
Clinical signs:
other: - during the exposition: irregular breathing, narrowed palpebral fissures and female animals showed additional stilted gate - no more clinical signs were observed in males 330 minutes p.a. and in females 450 minutes p.a.
Body weight:
- Body weight development was impaired in the first week, probably due to the frequent placement in metabolism cages.
- But all animals except for one female did excess their initial body weight at the end of the test period.
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female Wistar rats to 230 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 230 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. They were exposed to 230 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 230 mg/m³ for the inhalation of dust.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study performed using analogue substance
Justification for type of information:
See jusitifcation document in Chapter 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 250 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no death occurred
Clinical signs:
other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study performed using analogue substance
Justification for type of information:
See jusitifcation document in Chapter 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 230 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No death within observation period of 14 d
Mortality:
- no death occurred
Clinical signs:
other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study performed using analogue substance
Justification for type of information:
See jusitifcation document in Chapter 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 250 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no death occurred
Clinical signs:
other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study performed using analogue substance
Justification for type of information:
See jusitifcation document in Chapter 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 230 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No death within observation period of 14 d
Mortality:
- no death occurred
Clinical signs:
other: - within 3 to 4 hours after starting the exposure period rats showed dyspnoea, curved or ventral position and ruffled fur - recovery within 4 days
Gross pathology:
- no macroscopically visible changes were found
Interpretation of results:
GHS criteria not met
Conclusions:
Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³.
Executive summary:

Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). 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 > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol.

Classification for acute inhalation toxicity is not necessary according to Regulation (EC) No 1272/2008 .

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
4 250 mg/m³
Quality of whole database:
reliable

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:
1972
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 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
: no details given on the duration of the exposure; no details given on the occlusion made on the application site; dose tested (1710 mg/kg bw) is lower than the recommended limit dose (2000 mg/kg bw); only 7 days postobservation period
GLP compliance:
no
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: in house breeding
- Age at study initiation: 8 weeks
- Weight at study initiation: males mean: 322 g; females mean: 210 g
- Housing: single caged
- Diet: pelleted diet (Oakes of Congleton), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
not specified
Vehicle:
other: 50:50 mixture: polyethylene glycol/water
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg bw
- For solids, paste formed: yes (1 g of test item was mixed with 2.5 ml of vehicle)
Duration of exposure:
no data
Doses:
9.9 ml of paste per kg bw (equivalent to 3000 mg test item per kg bw)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Remarks on result:
other: corresponds to 1710 mg/kg bw pure Pigment Yellow 13; no animals died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
- no clinical symptoms were recorded
Gross pathology:
- No macroscopically visible changes occurred at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not toxic to male and female Sprague-Dawley rats after dermal application, resulting in a dermal LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).
The test was performed with the test item which contains relevant amounts of the submission substance. Therefore, the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg PY13/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).

Classification for acute dermal toxicity is not necessary according to Regulation (EC) No 1272/2008.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See read across justification document in Chapter 13
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponds to 1710 mg/kg bw pure Pigment Yellow 13; no animals died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
- no clinical symptoms were recorded
Gross pathology:
- No macroscopically visible changes occurred at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not toxic to male and female Sprague-Dawley rats after dermal application, resulting in a dermal LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).
The test was performed with the test item which contains relevant amounts of the submission substance. Therefore, the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg PY13/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).

Classification for acute dermal toxicity is not necessary according to Regulation (EC) No 1272/2008.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See read across justification document in Chapter 13
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponds to 1710 mg/kg bw pure Pigment Yellow 13; no animals died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
- no clinical symptoms were recorded
Gross pathology:
- No macroscopically visible changes occurred at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not toxic to male and female Sprague-Dawley rats after dermal application, resulting in a dermal LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).
The test was performed with the test item which contains relevant amounts of the submission substance. Therefore, the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg PY13/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).

Classification for acute dermal toxicity is not necessary according to Regulation (EC) No 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
1 710 mg/kg bw
Quality of whole database:
reliable

Additional information

Justification for classification or non-classification

Based on the reported study data Pigment Yellow 83 has not to be classified for acute toxicity according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.

Furthermore, Pigment Yellow 83 has not to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute exposure.