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Diss Factsheets

Administrative data

Description of key information

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Yellow 095, where the sulphonate group is bound at the meta-position of the amino benzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Yellow 095.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Yellow 095 meta/para (CAS# --- / EC# 944-218-2)
Target: Reactive Yellow 095 meta (CAS# 84045-63-6 / EC# 281-865-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 in rats was determined to be >2000 mg/kg bw.
Executive summary:

The source substance was administered to groups of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of the source substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. The structurally related target substance will show the same behaviour and therefore it can be anticipated that the acute oral LD50 will be >2000 mg/kg bw as well.

This is confirmed by 3 supporting studies performed with the source substance, showing LD50 values of >5000 mg/kg bw (twice) and 14530 mg/kg bw, respectively.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
None
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: Tif RAI strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 and 105 g
- Fasting period before study: Overnight
- Housing: macrolon cages (Size 3)
- Diet (e.g. ad libitum): standard diet of Nafag ad libitum
- Water (e.g. ad libitum):access of drinking water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-1°C
- Humidity (%): 55+5%
- Photoperiod (hrs dark / hrs light): 14-hour light period.

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
None
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
14 530 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: ataxia, dyspnoea, ventricumbency, slight muscular hypotonia, slight inhibition of the response to pain
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 40000 in rats is 14530 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 40000 was evaluated rats.1000, 3000, 10000 and 15000 mg/kg dose were administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. ataxia, dyspnoea, ventricumbency, slight muscular hypotonia, slight inhibition of the response to pain were observed. At autopsy no changes caused by the administration of FAT 40000 were seen. In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is 14530 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 153-218 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4 with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat fpod ad libitum
- Water (e.g. ad libitum): water ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3° C
- Humidity (%): 55+15%
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
None
Doses:
3000 and 5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by gavage.
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 40000/D in rats is greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 40000/D was evaluated rats.3000 and 5000 mg/kg dose were administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnoea, exophthalmus, ruffled fur and curved body position are symptoms commonly seen during the observation time following administration of substances by gavage. At autopsy no changes caused by the administration of FAT 40000/D were seen.In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
None
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 166-225 g
- Fasting period before study: overnight
- Housing: Macrolon cages
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity (%): 55+-15%
- Air changes (per hr): 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
Details on oral exposure:
None
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
None
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: Dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position curved
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 40000/E in rats is greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 40000/E was evaluated rats.5000 mg/kg dose was administered. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnoea, exophthalmos, ruffled fur, diarrhoea, body position (curved) were observed. At autopsy no changes caused by the administration of FAT 40000/E were seen.In conclusion, the acute oral LD50 of FAT 40000 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Principles of method if other than guideline:
None
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
None
Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks females: 10 weeks
- Weight at study initiation: males: 199 - 209 g females: 165 - 179 g
- Fasting: overnight
- Housing: Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard
- Water (e.g. ad libitum): Community tap water
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bidistilled
Details on oral exposure:
None
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 anmals per dose
Control animals:
yes
Details on study design:
None
Statistics:
The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred during the study period.
Clinical signs:
other: NO clinical signs were noted in the animals.
Gross pathology:
No macroscopical organ findings were observed.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 40000/G in rats is greater than 2000 mg/kg bw.
Executive summary:

The test article FAT 40000/G was administered to groups of 5 male and 5 female rats by oral gavage, at single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of FAT 40000/G in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the very low vapour pressure of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the inhalation route of exposure is considered to be unlikely, thus the study on acute inhalation toxicity is being waived.
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Yellow 095, where the sulphonate group is bound at the meta-position of the amino benzene moiety. The source chemical for most endpoints is the reaction mass of both the meta-isomer and the para-isomer of Reactive Yellow 095. The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
For this endpoint, the source chemical is Reactive Yellow 175 instead. This source chemical is used as it is also used by the registrants of the reaction mass of the meta-isomer and para-isomer of Reactive Yellow 095 to cover this endpoint.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Yellow 175 (CAS# 111850-27-2 / EC# 402-740-3)
Target: Reactive Yellow 095 meta (CAS# 84045-63-6 / EC# 281-865-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity LD50 in rat was determined to be >2000 mg/kg bw.
Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to the source substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin with a syringe and covered with an occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The toxicity of the test substance was estimated to be >2000 mg/kg bw.

The structurally related target substance will show similar behaviour.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
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: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, / Switzerland
- Age at start of treatment: 8 to 9 weeks
- Weight at start of treatment: Males: 212 - 221 g, Females: 162-185 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland).
- Diet: Pelleted standard Kliba 343, Batch 77/87 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: At least one week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4% in distilled water
Details on dermal exposure:
Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4mL of the test article was applied evenly on the skin with a syringe and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes, D.N. and Sanderson, D.M. "A method for determining the dermal toxicity of pesticides". Brit. J. Industr. Med., 26, 59-64, 1969)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Mortality/viability were measured four times during test day 1 and daily during days 2 - 15.
- Body weights were measured on day 1 (pre administration), 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15 (general behaviour, respiration, eye, nose, motility, body posture, motor susceptibility, skin)
Statistics:
The Logit model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0%
Clinical signs:
other: The rats showed yellowish discolored skin at the application site.
Gross pathology:
In two animals, several dark-red foci were observed in the lung.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity of the test substance was estimated to be greater than 2000 mg/kg bw
Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to the source substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin with a syringe and covered with an occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14-day observation period followed. No mortality was observed during this period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The toxicity of the test substance was estimated to be >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The source substance was administered to groups of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg. The acute oral toxicity of the source substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. The structurally related target substance will show the same behaviour and therefore it can be anticipated that the acute oral LD50 will be >2000 mg/kg bw as well.

This is confirmed by 3 supporting studies performed with the source substance, showing LD50 values of >5000 mg/kg bw (twice) and 14530 mg/kg bw, respectively.

A different source substance, REACTIVE YELLOW 175, was evaluated for the acute toxicity via dermal route.

In this GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were exposed to 2000 mg/kg bw (RCC 1987). No mortality was observed during the observation period. Discoloration of the application area was observed. In two animals several dark-red foci present in the lung were observed. The dermal LD50of the test substance was estimated to be >2000 mg/kg bw.

Justification for classification or non-classification

Based on the above assessment of the acute oral and dermal toxicity, the substance does not need to be classified for acute oral or dermal toxicity according to CLP (Regulation (EC) No 1272/2008).