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Endpoint summary

Description of key information

A LD50 greater than 2000 mg/kg bw was observed in both the acute oral and acute dermal toxicity study.

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:

Experiment start date - 21 December 2004; Experiment completion date - 13 January 2005; Study completion date - 02 February 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Age when treated: 12 weeks
- Fasting period before study: approximately 18 to 19 hours
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 42/04 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland), ad libitum.
- Water: Community tap water from Füllinsdorf ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

APPLICATION VOLUME: 10 mL/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Daily during the acclimatization period, at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: Macroscopic examinations were performed. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Slightly ruffled fur with hunched posture was noted in all animals of the first treated group at the 2- and 3-hour reading. Red soft faeces were present in the cage between the 1- and 5-hour reading. Red discoloration of the softwood bedding was also note

Gross pathology:

No macroscopic findings were recorded at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the observations the median lethal dose of the test substance is greater than 2000 mg/kg body weight

Executive summary:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 423, Wistar rats (2 groups of 3 females) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period. All animals survived until the end of the study period and no changes in body weights and macroscopic findings were observed. The only clinical signs observed, were slightly ruffled fur with hunched posture in all animals of the first treated group at the 2- and 3-hour reading and slightly ruffled fur in two animals of the second treated group from the 1- to 3-hour reading which persisted in one animal up to the 5-hour reading. Hunched posture was noted in the same animals at the 2- and 3-hour reading. Red soft faeces were present in the cage between the 1- and 5-hour reading of the first treated group and were also noted on test day 2. Red discoloration of the softwood bedding was also noted between the 2-hour reading and test day 2. Red faeces as well as red discoloration of the softwood bedding was also noted in the cage of the second treated group at the 1-hour reading and red soft faeces with red discoloration of the softwood bedding was noted up to test day 2. Slight sedation was noted in one animal from the 1- to the 3-hour reading and slight ataxia was noted in the same animal from the 2- to the 5-hour reading of the second treated group. Based on the observations, the median lethal dose of the test substance in female rats observed for a period of 14 days was greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP compliant guideline study, Klimisch Code 1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

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

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 22 December 2004; Experiment completion date - 12 January 2005; Study completion date - 02 February 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
- Age when treated: males: 8 weeks, females: 12 weeks
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. lndividually in Makrolon type-3 cages with standard softwood bedding ('Lignocel', Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 42/04 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland), ad libitum,
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test. On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

Application volume/kg body weight: 4 mL.
24 hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed. The fur of all animals was shaved on test day 9 just after the assessment of the reaction to facilitate the skin reading for the next day.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

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:
Mortality/Viability: Daily during the acclimatization period, at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
- Necropsy of survivors performed: Macroscopic examinations were performed. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Ruffled fur was noted at the 3-hour reading in three male animals and was persistent up to the 5-hour reading in two animals. Red discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all male an

Gross pathology:

No macroscopic findings were observed at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The toxicity of the test substance is 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 treated with the test substance (2000 mg/kg bw) by dermal application. The test substance was diluted in vehicle (polyethylene glycol), administered on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. After 24 hours the dressing was removed and the skin was flushed with lukewarm tap water. A 14-day observation period followed. No deaths occurred during the study and the body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed. Ruffled fur was noted at the 3-hour reading in three male animals and was persistent up to the 5-hour reading in two animals. Red discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all male animals on test days 2-4 and again on test days 7 to 13, or test days 9 or 10 to the end of the observation period. Slight crusts were noted on test days 2 to 5, 8 or 15. Red discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all female animals on test days 2- 4 and again from test day 6, 9 or 12 to the end of the observation period. Slight crusts were noted on test days 2 or 4 to 6, 8, 9 or 15. Based on the observations, the toxicity of the test substance is greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP compliant guideline study, Klimisch Code 1

Additional information

Acute toxicity, oral:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 423, Wistar rats (2 groups of 3 females) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period (RCC 2005). All animals survived until the end of the study period and no changes in body weights and macroscopic findings were observed. The only clinical signs observed, were slightly ruffled fur with hunched posture in all animals of the first treated group at the 2- and 3 -hour reading and slightly ruffled fur in two animals of the second treated group from the 1- to 3- hour reading which persisted in one animal up to the 5-hour reading. Hunched posture was noted in the same animals at the 2- and 3-hour reading. Red soft faeces were present in the cage between the 1- and 5-hour reading of the first treated group and were also noted on test day 2. Red discoloration of the softwood bedding was also noted between the 2-hour reading and test day 2. Red faeces as well as red discoloration of the softwood bedding was also noted in the cage of the second treated group at the 1-hour reading and red soft faeces with red discoloration of the softwood bedding was noted up to test day 2. Slight sedation was noted in one animal from the 1- to the 3-hour reading and slight ataxia was noted in the same animal from the 2- to the 5-hour reading of the second treated group. Based on the observations, the median lethal dose of the test substance in female rats observed for a period of 14 days was greater than 2000 mg/kg bw.

 

Acute toxicity, dermal:

In a GLP-compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were treated with the test substance (2000 mg/kg bw) by dermal application (RCC 2005). The test substance was diluted in vehicle (polyethylene glycol), administered on the skin with a syringe and covered with a semi-occlusive dressing for 24 hours. After 24 hours the dressing was removed and the skin was flushed with lukewarm tap water. A 14-day observation period followed. No deaths occurred during the study and the body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed. Ruffled fur was noted at the 3-hour reading in three male animals and was persistent up to the 5-hour reading in two animals. Red discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all male animals on test days 2-4 and again on test days 7 to 13, or test days 9 or 10 to the end of the observation period. Slight crusts were noted on test days 2 to 5, 8 or 15. Red discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all female animals on test days 2- 4 and again from test day 6, 9 or 12 to the end of the observation period. Slight crusts were noted on test days 2 or 4 to 6, 8, 9 or 15. Based on the observations, the toxicity of the test substance is greater than 2000 mg/kg bw.

 

Acute toxicity, inhalation - waiver

Currently no study to assess the acute inhalation toxicity potential of Reactive Red 280 is available. The calculated value for vapour pressure was found to be 2.19E-31 Pa at 25 °C. Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, 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 expected low volatility of the substance, the fact that the chemical is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. Further, the chemical is found to have water solubility of at least 337 g/L, hence, in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral (LD₅₀: >2000 mg/kg bw) and dermal (LD₅₀: >2000 mg/kg bw) toxicity studies, with no systemic toxicity being seen, hence it does not need to be classified STOT SE and low toxicity is expected for this chemical via the inhalation route. Taking the above arguments into consideration, low toxicity potential is expected on acute exposure of Reactive Red 280 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the observed LD50 of >2000 mg/kg bw in the acute oral and dermal toxicity study, the test substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.