4-isopropyl-m-cresol

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 > 2200 mg/kg bw  (similar to OECD 401 in mice, WoE);
Acute toxicity: inhalation: LC50 > 1.41 mg/L (maximim attainable atmosphere concentration) (OECD 403, rats, K, rel.1)
Acute toxicity: dermal: LD50 >2000 mg/kg bw (OECD 402, rats, K, rel. 1);

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:

weight of evidence

Study period:

February 26 to March 04, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similar to OECD test Guideline No. 401 and before the GLP compliance. 7 days observation followed instead of 14 days observation

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Old study before GLP. No details about the substance (purity, conditions of storage, etc). 7 days observation followed instead of 14 days observation.

Principles of method if other than guideline:

Groups of mice (7 mice of both sexes/ dose) were administered the test substance by gavage at two different doses (10 mL/kg bw and 22 mL/kg bw). The animals were observed for 7 days before necropsy. The LD50 is determined.

GLP compliance:

no

Remarks:

Study conducted before GLP compliance applied

Test type:

standard acute method

Limit test:

no

Species:

mouse

Strain:

other: Slc-ddy strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuoka Test Animal Laboratory
- Age at receipt: 4 weeks
- Weight at study initiation: 20.0-24.1 g (males); 19.0-22.3 g (females)
- Fasting period before study: None
- Housing: Seven mice were housed in the plastic cages (manufactured by Japan Klare Co., Ltd.) wood out in the bottom.
- Diet: Solid food (CE-2; manufactured by Japan Klare Co., Ltd.), ad libitum
- Water, ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Humidity: 55 ± 5 %

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

10% test substance in an aqueous suspension of 0.5% CMC was given by stomach tube to two groups of both sexes mice.

Doses:

10 and 22 mL/kg bw (1000 and 2200 mg/kg bw, respectively)

No. of animals per sex per dose:

7 mice of both sexes/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: General conditions and mortality were observed for one week after dosing. Each mouse was weighed every day (except Sunday).
- Necropsy of survivors performed: Yes; Survivors were sacrificed under the ether anesthesia on day 8 after dosing.

Statistics:

No data

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 (male and female) > 2200 mg/kg bw. Under the test conditions, parathymol is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

Executive summary:

In an acute oral toxicity study performed equivalent to OECD Guideline No. 401, groups of mice (7 mice of both sexes/ dose) was given a single oral dose of 10% CMC diluted Biosol at dose level of 10 and 22 mL/kg bw corresponding to 1000 and 2200 mg/kg bw, respectively. Animals were observed daily for mortality, clinical signs and bodyweights for 7 days. At the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or systemic toxicity was observed up to the end of observation. No body weight change was observed in males at 10 mL/kg bw. Males at 22 mL/kg bw and females at 10 and 22 mL/kg bw showed reduction in body weight gain on the 1st day after dosing. However, weight gain was normal thereafter. No abnormalities were noted at necropsy.

 

Oral LD50 (male and female) > 2200 mg/kg bw. 

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. 

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 200 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven data requirements of REACH. Moreover, reliability and consistency are observed across the different studies.

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

Study period:

From September 24 to October 23, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD test Guideline No. 403 without any deviation.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other 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

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on December 02, 2002/ signed on February 13, 2003)

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: Charles River (UK) Ltd, Margate, Kent.
- Age at study initiation: Approximately 8-12 weeks
- Weight at study initiation: 200-350 g
- Housing: Animals were housed in groups of five per sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels"
- Diet: Food (EU Rodent Diet 5LF2, IPS Limited, Wellingborough, Northants, UK), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 15%
- Air changes: 15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From September 24 to October 23, 2003

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

other: compressed air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Cylindrical exposure chamber; dynamic (continuous flow)
- Exposure chamber volume: Approximately 30 L (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by rubber 'O' ring. Only the nose of each animal was exposed to the test atmosphere.
- Source and rate of air: Compressed air was supplied by an oil free compressor; chamber flow rate was maintained at 40 L/min providing 80 air changes per hour
- Method of conditioning air: Air was passed through a water trap and respiratory quality filters before it was introduced into the SAG 410.
- Atmosphere generation: A dust atmosphere was produced from the test material using a SAG 410 Solid Aerosol Generator (TOPAS GmbH, Dresden, Germany) located adjacent to the exposure chamber. The SAG 410 was connected to a metered compressed air supply.
- Method of particle size determination: The particle size of generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor (Schaefer Instruments Ltd, Oxon., UK).
- Temperature and relative humidity inside the exposure chamber was measured by an electronic thermometer/humidity meter located in a vacant part in the animal's breathing zone of the chamber and recorded every thirty minutes throughout the 4 hours exposure period.
- Exposure chamber oxygen concentration was measured by an electronic oxygen analyser (Servomex (UK) Ltd, Crowborough, East Sussex) located in a sampling part in the animal's breathing zone during each exposure period.

TEST ATMOSPHERE
- Brief description of analytical method used:
Gravimetric method: Air in the breathing zone was drawn through glass fibre filters (Gelman type A/E 25 mm) and the employed filters weighed before and after sampling. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
- Samples taken from breathing zone: Yes

TEST ATMOSPHERE
- See the table 7.2.2/1 and 7.2.2/1

- Prior to the start of the study, test material atmospheres were generated within the exposure chamber. During this characterisation period, extensive work was performed in an attempt to achieve a sustainable atmosphere at maximum concentration. This included alternative grinding techniques and varying the generation system. No significant improvement could be made to the achieved atmosphere concentrations or particle size distributions and therefore, the concentration achieved is considered the maximum attainable.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetric method

Duration of exposure:

4 h

Concentrations:

Nominal concentration: 77.0 mg/L
Mean maximum attainable atmosphere concentration: 1.41 mg/L

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: All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days. All animals were observed for mortality throughout the study period.
- Frequency of weighing: Individual bodyweights were recorded prior to treatment on the day of exposure and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of 14 days observation period the animals were killed by intravenous overdose of sodium pentobarbitone and subjected to complete external and internal examination for macroscopic abnormalities. The respiratory tract was examined macroscopically for signs of irritancy or local toxicity.

Statistics:

None

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.41 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: no mortality was observed

Mortality:

No mortality was observed throughout the study period

Clinical signs:

other: - Signs of hunched posture, pilo-erection and red/brown staining around the snout and/or eyes are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded both during and for

Body weight:

- Normal bodyweight gain was observed during the study.
- Several females showed reduction in body weight gain or a slight body weight loss during Week 1 and/or 2 but such variations are not uncommon in female rats of this strain and age are considered not to be significant.

Gross pathology:

No macroscopic abnormalities were detected at necropsy.

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The combined inhalational LC50 was greater than 1.41 mg/L (mean maximum attainable atmosphere concentration). Under the test conditions, test item should not be classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute inhalational toxicity study performed in accordance with GLP and OECD guideline 403, groups (5/sex) of Sprague Dawley Crl:CD® (SD) IGS BR rats were exposed to a dust atmosphere of Biosol at the mean maximum attainable atmosphere concentration of 1.41 mg/L air (nominal concentration: 77.0 mg/L) for 4 hours. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and necropsy was performed in all animals for macroscopical examination.

 

Common abnormalities noted during the study included increased respiratory rate, hunched posture and pilo-erection and there were isolated instance of red/brown staining to the eyes and/or snout. All animals recovered quickly to appear normal from Day 1 or 2 post-exposure. Normal bodyweight gain was observed during the study. Several females showed reduction in body weight gain or a slight body weight loss during Week 1 and/or 2 but such variations are not uncommon in female rats of this strain and age are considered not to be significant. No macroscopic abnormalities were detected at necropsy.

The combined inhalational LC50 was greater than 1.41 mg/L (mean maximum attainable atmosphere concentration).

 

Under the test conditions, test item should not be classified according to the criteria of the Annex VI of the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

1 410 mg/m³ air

Quality of whole database:

The available information as a whole meets the tonnage driven data requirements of REACH. Moreover, reliability and consistency are observed across the different studies.

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:

From June 19 to July 03, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline No. 402 without any deviation.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other 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

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on March 12-14, 2014/ signed on May 12, 2014

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: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: At least 200 g
- Housing: Animals were housed individually during the 24 h exposure period and in groups of five by sex for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Food (2014C Teklad Global Rodent diet supplied by, Harlan Laboratories UK Limited, Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From June 19 to July 03, 2014

Type of coverage:

semiocclusive

Vehicle:

other: moistened with dimethyl sulphoxide

Details on dermal exposure:

TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- For the purpose of the study the test item was weighed out according to each animal’s individual body weight and moistened with dimethyl sulphoxide prior to application.

TEST SITE
- Area of exposure: Back and flank area
- % coverage: The appropriate amount of test item, moistened with dimethyl sulphoxide, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area).
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 h contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with dimethyl sulphoxide followed by distilled water to remove any residual test item. The animals were returned to group housing for the remainder of the study period.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: Yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality or clinical signs of toxicity at 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.
- Necropsy of survivors performed: Yes; at the end of the study animals were killed by cervical dislocation and subjected to gross necropsy.

Statistics:

None

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

other: - No signs of systemic toxicity were noted during the observation period. - Dermal reactions: Very slight erythema (score 1) and hemorrhage of dermal capillaries were noted at the test sites of two males on Day 1; one male continued to show very slight er

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 Combined > 2000 mg/kg bw.  Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. 

Executive summary:

In an acute dermal toxicity study (limit test) performed according to OECD Guideline No. 402 and in compliance with GLP, a group of Wistar (RccHan^TM:WIST) rats (5/sex) was given a single dermal application of the undiluted test material to intact skin of the back and flank area at a dose level of 2000 mg/kg bw. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Skin irritation was assessed and scored according to the Draize scale at 24 h after removal of the dressings and then daily for 14 days. 

No mortality or systemic toxicity was observed. Very slight erythema (score 1) and hemorrhage of dermal capillaries were noted at the test sites of two males on Day 1; one male continued to show very slight erythema (score 1) on Day 2. Very slight erythema (score 1) was noted at the test site of one female on Day 5 and crust formation was noted at the test sites of three females on Day 5. Crust formation persisted at the treatment site of two females from Days 6 to 8. Small superficial scattered scabs and glossy skin were noted at the test sites of two females from Days 5 to 8. All animals showed gains in body weight over the observation period. No abnormalities were noted at necropsy.

 

Dermal LD50 Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC. 

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven data requirements of REACH. Moreover, reliability and consistency are observed across the different studies.

Additional information

Acute toxicity: oral

Two studies are considered as acceptable and satisfies the requirement for acute oral toxicity endpoint if they are considered in a weight of evidence approach.

In the first acute oral toxicity study performed equivalent to OECD Guideline No. 401, groups of mice (7 mice of both sexes/ dose) was given a single oral dose of 10% CMC diluted Biosol at dose level of 10 and 22 mL/kg bw corresponding to 1000 and 2200 mg/kg bw, respectively. Animals were observed daily for mortality, clinical signs and bodyweights for 7 days. At the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or systemic toxicity was observed up to the end of observation. No body weight change was observed in males at 10 mL/kg bw. Males at 22 mL/kg bw and females at 10 and 22 mL/kg bw showed reduction in body weight gain on the 1st day after dosing. However, weight gain was normal thereafter. No abnormalities were noted at necropsy.

Oral LD50 (male and female) > 2200 mg/kg bw. 

In the second acute oral toxicity study performed equivalent to OECD Guideline No. 401, groups of mice (8 males/dose) was given a single oral dose of Biosol at 2500 and 6280 mg/kg bw by intragastric injection. General symptoms were observed, and survival or death was judged until 24 hours after administration, then LD50 was calculated by the Bliss’s probit method.

Clinical signs such as decrease in locomotor activity, piloerection, hind limb paralysis and tachypnea were induced after test substance administration. Paralytic symptoms were found around 1 hour after oral administration at the dose of 2500 mg/kg bw, and there were cases of death showing no recovery after 5 to 6 hours.

Oral LD50 (male): 6280 mg/kg bw

 

Acute toxicity: inhalation

A key tudy was identified (Safepharm, 2004).

This acute inhalational toxicity study was performed according to OECD guideline 403 and in compliance with GLP. Groups (5/sex) of Sprague Dawley Crl:CD® (SD) IGS BR rats were exposed to a dust atmosphere of Biosol at the mean maximum attainable atmosphere concentration of 1.41 mg/L air (nominal concentration: 77.0 mg/L) for 4 hours. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and necropsy was performed in all animals for macroscopical examination.

Common abnormalities noted during the study included increased respiratory rate, hunched posture and pilo-erection and there were isolated instance of red/brown staining to the eyes and/or snout. All animals recovered quickly to appear normal from Day 1 or 2 post-exposure. Normal bodyweight gain was observed during the study. Several females showed reduction in body weight gain or a slight body weight loss during Week 1 and/or 2 but such variations are not uncommon in female rats of this strain and age are considered not to be significant. No macroscopic abnormalities were detected at necropsy.

The combined inhalational LC50 was greater than 1.41 mg/L (mean maximum attainable atmosphere concentration).

 

Acute toxicity: dermal

A key study was identified (Harlan, 2014).

In this acute dermal toxicity study (limit test) performed according to OECD Guideline No. 402 and in compliance with GLP, a group of Wistar (RccHanTM:WIST) rats (5/sex) was given a single dermal application of the undiluted test material to intact skin of the back and flank area at a dose level of 2000 mg/kg bw. Test sites were covered with a semi-occlusive dressing for 24 h. Animals were observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination. Skin irritation was assessed and scored according to the Draize scale at 24 h after removal of the dressings and then daily for 14 days. 

No mortality or systemic toxicity was observed. Very slight erythema (score 1) and hemorrhage of dermal capillaries were noted at the test sites of two males on Day 1; one male continued to show very slight erythema (score 1) on Day 2. Very slight erythema (score 1) was noted at the test site of one female on Day 5 and crust formation was noted at the test sites of three females on Day 5. Crust formation persisted at the treatment site of two females from Days 6 to 8. Small superficial scattered scabs and glossy skin were noted at the test sites of two females from Days 5 to 8. All animals showed gains in body weight over the observation period. No abnormalities were noted at necropsy.

 

Dermal LD50 Combined > 2000 mg/kg bw

Justification for selection of acute toxicity – oral endpoint
Two studies are considered as acceptable and satisfies the requirement for acute oral toxicity endpoint if they are considered in a weight of evidence approach.

Justification for selection of acute toxicity – inhalation endpoint
The key study is GLP-compliant and of high quality (Klimisch score = 1)

Justification for selection of acute toxicity – dermal endpoint
The key study is GLP-compliant and of high quality (Klimisch score = 1)

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available data, Parathymol is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity via Dermal route:

Based on the available data, Parathymol is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 2000 mg/kg bw.

Acute toxicity (Inhalation):

Based on the available data, Parathymol is not classified according to the Regulation (EC) No. 1272/2008 as the LC50 is greater than the maximum attainable atmosphere concentration.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no significant health effects were observed immediately or delayed after exposure at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal):

The classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw ≥ C > 1000 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Inhalation):

The classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed up to the maximum attainable atmosphere concentration.