Cyclopropanecarboxylic acid, 2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl ester

Endpoint summary

Description of key information

Oral: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off can be considered to be > 5000 mg/kg bw, female rat, OECD TG 423, 2004

Acute Inhalation toxicity: measured LC50 > 5.1 mg/L (mean achieved concentration), OECD TG 403, 2015

Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2004

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:

07-05-2004 to 01-06-2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

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)

Remarks:

inspected: November 2002 ; signature: March 2003

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

HanBrl: WIST (SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: 12 weeks
- Weight at study initiation: 157.1 - 171.5 g
- Fasting period before study: 18-19h (overnight)
- Housing: The animals were housed in 3 per cage suspended solid-floor cages furnished with woodflakes (cage enrichment)
- Water: ad libitum
- Acclimation period: 7 days, under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 (controlled)
- Humidity (%): 30-70 (controlled) (values above 70% possible during cleaning process)
- Air changes (per hr): 10-15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark, controlled cycle, music during daylight period.

IN-LIFE DATES: From: 07-05-2004 To: 01-06-2004

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg test item in 10 mL vehicle (200 mg/mL)
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Choice based on the results of a non-GLP solubility trial (documented in the full study report).
- Lot/batch no. (if required): 448174/1 21203148.
- Purity: Not specified; source documented in the full study report

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): Not applicable.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test item was toxic, 2000 mg/kg was chosen as the starting dose.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to and then 1, 2, 3 and 5 hours after dosing; twice daily. Individual bodyweights prior to and at 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities.

Clinical signs:

other: Hunched posture observed from the 1 hour to 5 hours reading in three of six females. Slightly ruffled fur observed in the same three females from 1-hour to test day 6. Slightly-ruffled fur was also noted in two females at the 2 and 3 hours examinations.

Gross pathology:

No abnormalities were noted at necropsy.

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test item oral median LD50 was determined to be greater than 2000 mg/kg bw in female HanBrl: WIST (SPF) strain rat.

Executive summary:

The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity under GLP to assess the acute oral toxicity of the test item following a single oral administration in the HanBrl: WIST (SPF) strain rat. A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test item was administered orally in a vehicle of 10 mL PEG-300. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no mortalities. Hunched posture was noted in three of six females during the day of dosing and up to 4 hours after dosing. Additionally, these three females were observed to have slightly ruffled fur from the day of dosing to test day 6. Slightly ruffled fur was noted in two of the other females, but only during two examinations on the day of dosing. All females showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female HanBrl: WIST (SPF) strain rat was estimated to be greater than 2000 mg/kg bw. Applicant assessment indicates: under the conditions of this study the acute toxicity estimate would be considered to be > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

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:

07-11-2014 to 21-11-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

inspected: March 2013 ; signature: May 2013

Test type:

traditional method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI(Han) (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: Approximately the same age and body weight variation did not exceed +/- 20% of the sex mean (292-312g (males), 287-209g (females)).
- Fasting period before study: Not specified.
- Housing: Group housing of five animals per sex per cage in labelled Makrolon cages (type IV), containing sterilised sawdust bedding and paper cage enrichment.
- Diet (e.g. ad libitum): Certified diet from recognised supplier (pelleted rodent diet SM R/M-Z), provided ad libitum (except for exposure period)
- Water (e.g. ad libitum): mains drinking water, ad libitum (except for exposure period period)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

IN-LIFE DATES: From: 07-11-2014 To: 21-11-2014

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

>= 2.3 - <= 2.4 µm

Geometric standard deviation (GSD):

>= 1.9 - <= 2.2

Remark on MMAD/GSD:

MMAD/GSD relates to: 7.8 mg/L (nominal), 5.1 ± 0.1 mg/L (mean achieved concentration) dose - determined twice during the study

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: An aerosol was generated by nebulization of the test substance by means of a nebulizer (type 950) and pressurized air. The test substance was transferred to the nebulizer by means of a rotating pump. The primary aerosol was diluted with pressurized air before it entered the exposure chamber
- Exposure chamber volume: approximately 150 mL. Was consistent with Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983.
- Method of holding animals in test chamber: Polycarbonate restraining tubes.
- Source and rate of air: filtered air, at least 26L/min mean total airflow.
- Method of conditioning air: not specified.
- System of generating particulates/aerosols: nebulizer; the chamber mean total flow rate was maintained at 26 L/min.
- Method of particle size determination: Particle size was determined using a cascade impactor. The device consisted of eight impactors stages containing fiber glass filters.
- Treatment of exhaust air: From the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.
- Temperature, humidity, in air chamber: The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter: 19.4-19.9°C, 17-18% relative humidity.

TEST ATMOSPHERE
- Brief description of analytical method used: Actual concentration was determined nineteen times during the exposure period. Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber. The collected amount of the test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter. The time-weighted mean concentration with the standard deviation was calculated. Full details of the analytical method are provided in the full study report.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The particle size of the generated atmosphere inside the exposure chamber was determined two times during each exposure period using a cascade impactor. The particle size distribution for each group is reported in table 1.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The Mass Median Aerodynamic Diameter (MMAD) was determined and is reported for each group in table 1.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

7.8 mg/L (nominal), 5.1 mg/L (mean achieved concentration) with a generation efficiency of 66%.

No. of animals per sex per dose:

5 per sex per dose. Full details are provided in table 2.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality, twice daily. Clinical signs three times during exposure and on day one at one and three hours and then once daily. Any evidence of mortality or overt toxicity was recorded at each observation. Individual body weights were recorded prior to treatment on the day of exposure and on Days 2, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and any other relevant toxicological effects were reported.

Statistics:

No statistical analysis was performed.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortalities occurred during the study period.

Clinical signs:

other: During exposure, slow breathing was seen for the animals (not presented in the table). After exposure, hunched posture was seen for one female on Days 2 and 3. No other clinical signs were seen for the animals.

Body weight:

The mean bodyweight of the animals decreased on day 2 (males and females) and was static on day 4 (females only). All animals gained weight thereafter.

Gross pathology:

No abnormalities were found at macroscopic examination.

Other findings:

- Organ weights: Not reported.
- Histopathology: Not applicable (no macroscopic findings noted)
- Potential target organs: Not applicable.
- Other observations: Not applicable.

Additional comments regarding test atmosphere generation:

It is noted within the study that the time-weighted mean actual concentration was 5.1 ± 0.1 mg/L and that the generation efficiency was 66%. The concentration measurements equally distributed over time demonstrated that the atmosphere was sufficiently stable at the mean total airflow of 26 L/min. Full details are available within the full study report.

 

Table 1. Characteristics of the achieved atmosphere:

Group Number	Mean Achieved Atmosphere Concentration (mg/L)	Mean Mass Median Aerodynamic Diameter (µm)	Geometric Standard Deviation	Comments
1	5.1	> 2.3 - < 2.4	> 1.9 - < 2.2

 

Table 2. Mean achieved atmosphere concentrations:

Group Number	Mean Achieved Atmosphere Concentration (mg/L)	Standard Deviation	Nominal (mg/L)
1	5.1	0.1	7.8

 

Table 3. Mortality data summary:

Group Number	Mean Achieved Atmosphere Concentration (mg/L)	Mortalities
		Female	Male	Total
1	5.1	0/5	0/5	0/10

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the inhalation 4h-LC50 (male/female) was considered to be > 5.1 mg/L within the Crl:WI(Han) rat.

Executive summary:

The study was performed according to OECD TG 403, EU Method B.2, US EPA OPPTS 870.1300 and Japanese JMAFF guidelines in accordance with GLP to assess the acute inhalation toxicity of the test item. A single group of ten Wistar: Crl:WI(Han) strain rats (five males and five females) were exposed to an aerosol atmosphere of the test item. The groups were exposed for four hours using a nose only exposure system, followed by a fifteen day observation period. The mean achieved atmosphere concentrations were as follows: 5.1 ± 0.1 mg/L based on a nominal concentration of 7.8 mg/L. The characteristics of the achieved atmosphere where Mean Mass Median Diameter (particle size): > 2.3 μm and < 2.4 μm with geometric Standard Deviation > 1.9 and < 2.2. There were no mortalities in the 5.1 mg/L mean achieved atmosphere concentration. Slow breathing was noted during exposure. After exposure, no clinical signs were observed among the males, whereas hunched posture was observed on days 2 and 3 only for one female. The affected female had recovered from the signs between Days 3 and 4. Body weight loss was noted in some male/females during the first two days post-exposure. All males/females regained weight during the remainder of the observation period. No abnormalities were found at macroscopic post-mortem examination. Under the conditions of this study, the inhalation 4h-LC50 (male/female) was considered to be > 5.1 mg/L within the Wistar: Crl:WI(Han) rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 100 mg/m³ air

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

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:

14-05-2004 to 06-07-2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

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)

Remarks:

inspected: November 2002 ; signature: March 2003.

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

HanBrl: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised supplier.
- Females (if applicable) nulliparous and non-pregnant: Not specified.
- Age at study initiation: ca. 8 weeks age (males); ca. 12 weeks age (females)
- Weight at study initiation: 230 – 251 g (males); 197 – 215 g (females)
- Fasting period before study: Not applicable
- Housing: during acclimation and observation period: group housed by sex; during exposure: individually housed in polycarbonate cages furnished with softwood bedding.
- Diet (e.g. ad libitum): Certified diet from recognised supplier, ad libitum.
- Water (e.g. ad libitum): Community tap water, ad libitum.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C (22 ± 3 °C)
- Humidity (%): 30 - 70% (values above 70% possible during cleaning process).
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: automatically controlled cycle of 12 h light / 12 h dark; music during daytime light period.

IN-LIFE DATES: From: To: 07-05-2004 to 28-05-2004

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Not specified the day before treatment the backs were clipped free of hair.
- % coverage: Approximately 10% of total body surface
- Type of wrap if used: The area of application was covered by a semi-occlusive dressing and wrapped with a piece of elastic self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour contact period the bandage was carefully removed and the treated skin flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (or dose volume 2.073 mL/kg)
- Concentration (if solution): See below.
- Constant volume or concentration used: 2.07 mL volume /kg bw used, providing a consistent dose level of 2000 mg/kg bw test item.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 per sex per dose (5 male/5 female)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality checks were conducted daily during the acclimatisation period, then at approximately 1, 2, 3 and 5 hours after administration on test day 1; Subsequent observations occured twice daily for days 2 to 15. Body weights were measured on test days 1 (prior to administration), 8 and 15. Local effects were examined twice daily days 2 to 15 after the completion of the 24-hour exposure period. Full details on the scoring and criteria (appears consistent with Draize for Erythema) are given in the full study report.
- Necropsy of survivors performed: yes

Statistics:

No statistical analyses were performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: - Clinical observations: None reported. - Dermal reactions: Slight scales were observed in all male animals from test day 5 or 6 to 8 and persisted in one animal up to day 10 and two animals up to day 11. Slight crusts were noted in one animal from test d

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Organ weights: Not reported.
- Histopathology: Not reported. No macropathological abnormalities.
- Potential target organs: Not applicable.
- Other observations: Not applicable.

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the dermal LD50 was established to exceed 2000 mg/kg bw in male/female Wistar ras. Applicant assessment indicates under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.

Executive summary:

The study was performed according to OECD TG 402 and EU Method B.3 Acute Toxicity (Dermal) and in accordance with GLP to assess the acute dermal toxicity of the test item in the HanBrl: WIST (SPF) strain rat. A group of ten animals (five males and five females) was given a single, 24 hour semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There was no mortality during the study. There were no signs of system toxicity or abnormalities on necropsy. It was considered there was no toxicologically significant effects on bodyweight. All males/females gained bodyweight during the study. No signs of dermal irritation were noted (score 0) up to day 14 in all females, and slight (score = 1) transient signs of dermal irritation were observed in males, with no signs of dermal irritation observed by the conclusion of the study. The dermal LD50 was established to exceed 2000 mg/kg bw in male/female HanBrl: WIST (SPF) rat. Applicant assessment indicates under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The available information as a whole meets the tonnage driven information requirements of REACH.

Additional information

ORAL:

Key study : OECD TG 420, 2004 : The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity under GLP to assess the acute oral toxicity of the test item following a single oral administration in the HanBrl: WIST (SPF) strain rat. A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test item was administered orally in a vehicle of 10 mL PEG-300. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no mortalities. Hunched posture was noted in three of six females during the day of dosing and up to 4 hours after dosing. Additionally, these three females were observed to have slightly ruffled fur from the day of dosing to test day 6. Slightly ruffled fur was noted in two of the other females, but only during two examinations on the day of dosing. All females showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female HanBrl: WIST (SPF) strain rat was estimated to be greater than 2000 mg/kg bw. Applicant assessment indicates: under the conditions of this study the acute toxicity estimate would be considered to be > 5000 mg/kg bw.

INHALATION:

Key study : OECD TG 403, 2015 : The study was performed according to OECD TG 403, EU Method B.2, US EPA OPPTS 870.1300 and Japanese JMAFF guidelines in accordance with GLP to assess the acute inhalation toxicity of the test item. A single group of ten Wistar: Crl:WI(Han) strain rats (five males and five females) were exposed to an aerosol atmosphere of the test item. The groups were exposed for four hours using a nose only exposure system, followed by a fifteen day observation period. The mean achieved atmosphere concentrations were as follows: 5.1 ± 0.1 mg/L based on a nominal concentration of 7.8 mg/L. The characteristics of the achieved atmosphere where Mean Mass Median Diameter (particle size): > 2.3 μm and < 2.4 μm with geometric Standard Deviation > 1.9 and < 2.2. There were no mortalities in the 5.1 mg/L mean achieved atmosphere concentration. Slow breathing was noted during exposure. After exposure, no clinical signs were observed among the males, whereas hunched posture was observed on days 2 and 3 only for one female. The affected female had recovered from the signs between Days 3 and 4. Body weight loss was noted in some male/females during the first two days post-exposure. All males/females regained weight during the remainder of the observation period. No abnormalities were found at macroscopic post-mortem examination. Under the conditions of this study, the inhalation 4h-LC50 (male/female) was considered to be > 5.1 mg/L within the Wistar: Crl:WI(Han) rat.

DERMAL:

Key study : OECD TG 402, 2004 : The study was performed according to OECD TG 402 and EU Method B.3 Acute Toxicity (Dermal) and in accordance with GLP to assess the acute dermal toxicity of the test item in the HanBrl: WIST (SPF) strain rat. A group of ten animals (five males and five females) was given a single, 24 hour semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There was no mortality during the study. There were no signs of system toxicity or abnormalities on necropsy. It was considered there was no toxicologically significant effects on bodyweight. All males/females gained bodyweight during the study. No signs of dermal irritation were noted (score 0) up to day 14 in all females, and slight (score = 1) transient signs of dermal irritation were observed in males, with no signs of dermal irritation observed by the conclusion of the study. The dermal LD50 was established to exceed 2000 mg/kg bw in male/female HanBrl: WIST (SPF) rat. Applicant assessment indicates under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.

Justification for classification or non-classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity: oral

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity: inhalation

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity: dermal