Sodium 3-nitrobenzenesulphonate

Endpoint summary

Description of key information

Acute oral toxicity: 

Acute oral toxicity dose (LD50) of test chemical was considered based on the different experimental studies conductred on rats, All these studies concluded that the LD50 is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute oral toxicity.

Acute Inhalation toxicity: 

Acute Inhalation toxicity dose (LC50) for test chemical was considered based experimental study conducted on rat is >5.1 mg/L (>5100 mg/m3). Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute Inhalation toxicity.

Acute Dermal toxicity: 

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute oral toxicity study for test chemical in rat.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight was 180 and 220 g for male dose groups 5000 and 2150, respectively, and 170 g for the two female dose groups.
Fasting period: 15 - 20 h before application

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

not specified

Doses:

2150, 5000 mg/kg b.w.

No. of animals per sex per dose:

5 (sex/dose)

Control animals:

not specified

Details on study design:

The substance was applied as a single oral dose as a 10 mL suspension. The post-exposure period was 14 days after which the animals were sacrificed and subjected to a gross-pathological examination.

Statistics:

not specified

Preliminary study:

not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no other details available

Mortality:

No mortality was observed at 5000 mg/kg bw.

Clinical signs:

other: Staggering was the only clinical symptom noted at the dose level of 5000 mg/kg b.w.

Gross pathology:

Gross pathology did not reveal any abnormal findings. Both sexes showed comparable results.

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

The above experimental results prove that the LD50 value for male and female rats was determined to be >5000 mg/kg b.w. Thus, test chemical is not expected to exhibit acute oral toxicity upto the dose levels mentioned in the present study

Executive summary:

Acute oral toxicity study was conducted according to OECD Guideline 401 (Acute Oral Toxicity) by using test chemical in 20 male and female Sprague-Dawley rats at the dose concentration of 2150 and 5000 mg/kg bw. The substance was applied as a single oral dose as a 10 mL suspension in CMC (carboxymethyl cellulose). The post-exposure period was 14 days after which the animals were sacrificed and subjected to a gross-pathological examination. No mortality was observed at 5000 mg/kg bw. Staggering was the only clinical symptom noted at the dose level of 5000 mg/kg b.w. Body weight changes was observed. Gross pathology did not reveal any abnormal findings. Both sexes showed comparable results. Therefore, LD50 was considered to be >5000 mg/kg bw, when 20 male and female Sprague-Dawley rats were treated with test chemical via oral gavage route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from experimental study report.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Acute Inhalation Toxicity of test chemical in rat.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight at the beginning of the study: male animals 262 +/- 7.5 g, female animals 185 +/- 3.3 g.
Age of the animals at the beginning of the study: approx . 8- 9 weeks
The animals were identified by color marking on the tail.
The animals were offered KLIBA rat/mouse laboratory diet and drinking water ad libitum during the post-exposure observation period.
The animals were kept in fully air-conditioned rooms in which a temperature in the range 20-24°C and relative humidity in the range 30-70% were regulated by means of a central air-conditioning system.
The animals were housed in groups of five in cages type D III of Becker, without bedding, with a light/dark rhythm of 12 hours.

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

not specified

Remark on MMAD/GSD:

not specified

Details on inhalation exposure:

The animals were restrained in tubes and their snouts projected into the inhalation chamber. The dust aerosol air mixture was generated with a dosing-wheel dust generator and the concentration was adjusted by varying the rotation of the metering disc. Air-flow was 1,500 l/h while the temperature was kept between 19 and 25°C. The limit-test procedure was applied.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Remarks on duration:

not specified

Concentrations:

5.1 mg/L

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp . 32 - 35) in accordance with tables of the BASF Computer Center.

Preliminary study:

not specified

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: no mortalities

Mortality:

No mortality was observed in treated rats.

Clinical signs:

other: Clinical examination reveiled 10/10 animals with eyelid closure over the whole course of the exposure period. Temporarily, 4/10 animals showed irregular respiration, 7/10 accelerated respiration, 3/10 intermittent respiration, 3/10 whooping respiration, 7

Body weight:

The body weight gain of male rats in the test group, compared with a historical control collective, was not affected by the substance over the total observation period.
The body weight gain of female rats in the test group, compared with a historical control collective, was slightly retarded in the second week of the observation period.

Gross pathology:

Sacrificed animals (males and females): no pathologic findings noted.

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

Under the experimental conditions chosen, the combined LC50 for test chemical (aerosol) was >5.1 mg/L. Also, from day 2 of the observation period onward, 10/10 animals were without findings. Hence it is concluded that the chemical is not expected to exhibit acute toxicity by the inhalation route. However, the substance is expected to be an irritant to the respiratory tract at high concentrations.

Executive summary:

Acute Inhalation Toxicity study was conducted according to OECD Guideline 403 (Acute Inhalation Toxicity) by using test chemical in 10 male and female Wistar rats at the concentration of 5.1 mg/L via nose/head only inhalation by aerosol route for 4 hours exposure. The animals were restrained in tubes and their snouts projected into the inhalation chamber. The dust aerosol air mixture was generated with a dosing-wheel dust generator and the concentration was adjusted by varying the rotation of the metering disc. Air-flow was 1,500 l/h while the temperature was kept between 19 and 25°C. The limit-test procedure was applied. Animals were observed for mortality and clinical signs for 14 days. The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp . 32 - 35) in accordance with tables of the BASF Computer Centre. No mortality was observed in treated rats. Clinical examination reviled 10/10 animals with eyelid closure over the whole course of the exposure period. Temporarily, 4/10 animals showed irregular respiration, 7/10 accelerated respiration, 3/10 intermittent respiration, 3/10 whooping respiration, 7/10 shallow respiration, 3/10 salivation, 10/10 restlessness and 10/10 attempts to escape. On day 1 of the post-exposure period, 6/10 animals showed a reddish smear and crusts on their noses and 7/10 animals had fur discoloured with test substance. From day 2 of the observation period onward, 10/10 animals were without findings. Body weight change was observed. In sacrificed animals (males and females) no pathologic findings were noted. Hence, LC50 was considered to be >5.1 mg/L (>5100 mg/m3), when 10 male and female Wistar rats were exposed with test chemical via nose/head only inhalation by aerosol route for 4 hours exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 100 mg/m³ air

Quality of whole database:

Data is Klimisch 2 and from experimental study report.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data from various test chemicals

Justification for type of information:

Data is summarized based on the available information from various test chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 3 acute dermal toxicity studies as- WoE 2, WoE 3 and WoE 4
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

1.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used.
- Weight at study initiation: The weight ranges of approximately 239.3 to 272.5 grams at initiation of dosing were used.
Body weights at the start :
Male
Mean : 270.14 g (= 100 %)
Minimum : 267.1 g (- 1.13 %)
Maximum : 272.5 g (+ 0.87 %)
Total No. of animals : 5
Female
2.Mean : 243.94 g (= 100 %)
4.Mean : 249.20 g (= 100 %)
2.Minimum : 239.3 g (- 1.90 %)
4.Maximum : 250.1 g (+ 2.53 %)
Minimum : 243.9 g (- 2.13 %)
Maximum : 255.3 g (+ 2.45 %)
Total No. of animals : 5
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 22.3 degree centigrade.
3.- Humidity (%): 55.7% to 59.6%.
4.- Humidity (%): 53.2% to 58.8%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the total body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No data available
- For solids, paste formed: Yes

VEHICLE
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

Duration of exposure:

24 hours

Doses:

A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).

No. of animals per sex per dose:

10 (5/sex).

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed:
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.

Evaluation of Dermal Reaction:
Dermal reaction was observed daily for study period of 14 days.

Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.

Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).

Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.

Statistics:

No data

Preliminary study:

No data

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no other details available

Mortality:

2. Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

Sex : Female
Group I –
Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

3.Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

Sex : Female
Group I –
Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

4.Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.

Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.

Clinical signs:

other: 2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not res

Gross pathology:

Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

Other findings:

2.- Other observations:
Evaluation of Dermal Reaction
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

Interpretation of results:

other: Not classified

Conclusions:

According to CLP regulation, the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

The above study is supported with another study conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

 

The above study is supported with another study conducted on rats The study now reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.   

Animals exhibited normal body weight gain through the study period of 14 days.

Gross pathological examination did not reveal any abnormalities attributable to the treatment. 

It was concluded that the acute dermal median lethal dose (LD50) of test chemical , when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 794 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from study report

Additional information

Acute oral toxicity:

The experimental study conducted by and was designed for the acute oral toxicity of test chemical according to OECD Guideline 401 (Acute Oral Toxicity) in 20 male and female Sprague-Dawley rats at the dose concentration of 2150 and 5000 mg/kg bw. The substance was applied as a single oral dose as a 10 mL suspension in CMC (carboxymethyl cellulose). The post-exposure period was 14 days after which the animals were sacrificed and subjected to a gross-pathological examination. No mortality was observed at 5000 mg/kg bw. Staggering was the on ly clinical symptom noted at the dose level of 5000 mg/kg b.w. Body weight changes was observed. Gross pathology did not reveal any abnormal findings. Both sexes showed comparable results. Therefore, LD50 was considered to be >5000 mg/kg bw, when 20 male and female Sprague-Dawley rats were treated with test chemical via oral gavage route.

The above study is supported by another experimental study conducted and was designed for the acute oral toxicity according to BASF-internal standard by using test chemical in 10 male and female Tuebinger mice at the dose concentration of 3200 mg/kg bw. The substance was applied as a single oral dose as a 30% in water. No mortality was observed at 3200 mg/kg bw. No abnormalities detected in treated mice. Therefore, LD50 was considered to be >3200 mg/kg bw, when 10 male and female Tuebinger mice were treated with test chemical via oral route.

The above experimental studies are also supported for the test chemical for the acute oral toxicity in rats at the concentration of 5000 mg/kg bw. No mortality was observed at dose 5000 mg/kg bw. Hence LD50 was considered to be >5000mg/kg bw, when rats were treated with test chemical via oral route.

All the above studies are further supported by test chemical, for acute oral toxicity conducted in rats at the concentration of 11000 mg/kg bw. 50% mortality was observed at dose 11000 mg/kg bw. Hence LD50 was considered to be 11000 mg/kg bw, when rats were treated with Sodium 3-nitrobenzenesulphonate (CAS no: 127-68-4test chemical via oral route.

Thus, based on the above studies,it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

The experimental study conducted was designed for the acute inhalation toxicity of test chemical according to OECD Guideline 403 (Acute Inhalation Toxicity) in 10 male and female Wistar rats at the concentration of 5.1 mg/L via nose/head only inhalation by aerosol route for 4 hours exposure. The animals were restrained in tubes and their snouts projected into the inhalation chamber. The dust aerosol air mixture was generated with a dosing-wheel dust generator and the concentration was adjusted by varying the rotation of the metering disc. Air-flow was 1,500 l/h while the temperature was kept between 19 and 25°C. The limit-test procedure was applied. Animals were observed for mortality and clinical signs for 14 days. The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp . 32 - 35) in accordance with tables of the BASF Computer Centre. No mortality was observed in treated rats. Clinical examination reviled 10/10 animals with eyelid closure over the whole course of the exposure period. Temporarily, 4/10 animals showed irregular respiration, 7/10 accelerated respiration, 3/10 intermittent respiration, 3/10 whooping respiration, 7/10 shallow respiration, 3/10 salivation, 10/10 restlessness and 10/10 attempts to escape. On day 1 of the post-exposure period, 6/10 animals showed a reddish smear and crusts on their noses and 7/10 animals had fur discoloured with test substance. From day 2 of the observation period onward, 10/10 animals were without findings. Body weight change was observed. In sacrificed animals (males and females) no pathologic findings were noted. Hence, LC50 was considered to be >5.1 mg/L (>5100 mg/m3), when 10 male and female Wistar rats were exposed with test chemical via nose/head only inhalation by aerosol route for 4 hours exposure.

Thus, based on the above study on test chemical, it can be concluded that LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute Inhalation toxicity.

Acute Dermal toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for structurally similar read across chemicals.The studies are summarized as below –

The reported study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

The above study is supported with another study conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.

 

The above study is supported with another study conducted on rats The study now reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.   

Animals exhibited normal body weight gain through the study period of 14 days.

Gross pathological examination did not reveal any abnormalities attributable to the treatment. 

It was concluded that the acute dermal median lethal dose (LD50) of test chemical , when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight.Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity and LC50 to be 5100 mg/m3 for acute inhalation toxicity,Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral, acute dermal and acute inhalation toxicity.