Registration Dossier

Administrative data

Description of key information

Oral (OECD 423), rat: LD50 > 300 mg/kg bw < 2000 mg/kg bw

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw

Inhalation (OECD 403), rat: LC50 > 1 mg/L air < 5 mg/L air

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:
13 Mar - 04 Apr 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted Dec 2001
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
Version / remarks:
2000
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8 - 9 weeks
- Weight at study initiation: 142 - 170 g
- Fasting period before study: Yes, the animals were deprived of food overnight (for a maximum of 20 h) prior to design and until 3 - 4 h after administration of the test item.
- Housing: Up to 3 animals of the same sex and same dosing group were housed together in polycarbonate cages (Makrolon MIV type; height 18 cm) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J. Rettenmaier & Söhne GmbH + CO KG, Rosenberg, Germany). Animals were separated during designated procedures/activities.
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: 13 Mar 2018 To: 04 Apr 2018
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSAGE PREPARATION:
Dose volume (mL/kg body weight) was calculated as follows: Dose level (g/kg) / specific gravity or density (g/mL).
The test item was stirred continuously during dose administration.

CLASS METHOD:
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guideline. The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg/kg. Based on the results, two additional groups were dosed at 300 mg/kg.
Doses:
300 mg/kg bw (2 groups) and 2000 mg/kg bw (1 group)
No. of animals per sex per dose:
3 females in each group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Animals were weighed individually on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: Yes, all animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
500 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: 3/3 animals died on Day 1.
300 mg/kg bw: No mortality occurred.
Clinical signs:
2000 mg/kg bw: Tonic spasms, paddling movements, lateral recumbency, gasping, piloerection and hypersensitivity to touch were observed for all animals on Day 1.
300 mg/kg bw: Hunched posture was observed in 2/3 animals of the first group and in all animals of the second group on Day 1 and in 1/3 animals of the first group on Days 1 and 2. Piloerection and salivation were noted in all animals of both groups on Day 1.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.
Interpretation of results:
other: Acute Oral 4, H302 according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: Acute Oral 4, H302 according to Regulation (EC) 1272/2008
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006.

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:
24 - 29 Mar 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
2 dose levels only
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted 07 Sep 2009
Deviations:
yes
Remarks:
only 2 dose groups instead of 3
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Version / remarks:
EC No 440/2008, part B., May 2008, ammended by Comission Regulation (EU) No. 260/2014 (24 January 2014)
Deviations:
yes
Remarks:
only 2 dose groups instead of 3
Qualifier:
according to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Version / remarks:
adopted Aug 1998
GLP compliance:
yes
Test type:
traditional method
Limit test:
no
Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han), Outbred, SPF-Quality
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10-13 weeks
- Weight at study initiation: 316 – 386 g (males) and 209 – 251 g (females)
- Housing: 5 animals of the same sex and same dosing group were housed together in polycarbonate cages (Makrolon MIV type; height 18 cm) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J. Rettenmaier & Söhne GmbH + CO KG, Rosenberg, Germany). Animals were separated during designated procedures/activities.
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
> 3.4 - < 4.3 µm
Remark on MMAD/GSD:
The Mass Median Aerodynamic Diameter (MMAD) ± Geometric Standard Deviation (GSD) was 3.4 ± 2.0 µm and 3.6 ± 1.9 µm at 1 mg/L air and 4.3 ± 1.7 µm and 3.7 ± 1.8 µm at 5 mg/L air, respectively. Agglomeration of aerosol particles at this high concentration might have resulted in the MMAD values to fall outside the recommended range of 1 - 4 µm. The MMAD just exceeded this range and there was no evidence for item deposition in the upper airways. Since it is generally known that good distribution throughout the lung requires particles with an aerodynamic diameter between 1 and 5 μm, it can be assumed that sufficient deposition in the lower respiratory tract occurred during the exposure.
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Polycarbonate restraining tubes, which were connected to the exposure chamber. The chamber consists of animal sections with eight animal ports each. Each animal port has its own test atmosphere inlet and exhaust outlet. The number of animal sections and number of open inlets were adapted to the air flow in such a way that at each animal port the theoretical air flow was at least 1 L/min. The main inlet of the test atmosphere was located at the top section and the main outlet was located at the bottom section. The direction of the flow of the test atmosphere guaranteed a freshly generated atmosphere for each individual animal. All components of the exposure chamber in contact with test item were made of stainless steel, glass, rubber or plastic.
- Rate of air: 1 L/min
- System of generating aerosols: An aerosol was generated by nebulization of the test item using a Collison nebulizer. The primary aerosol was let through a cyclone, allowing large particles to settle, and diluted with pressurized air before it entered the exposure chamber. The mean total airflows were 39 and 19 L/min, at 1 and 5 mg/L, respectively.
- Method of particle size determination: The particle size distribution was characterized twice during each exposure period. The samples were drawn with a flow of 2 L/min. From the test atmosphere through a tube mounted in one of the free animal ports of the exposure chamber. The samples were collected with an 8 stage Marple personal cascade impactor containing fiber glass filters and a fiber glass back-up filter. Amounts of test item collected were measured gravimetrically. Subsequently the Mass Median Aerodynamic Diameter (MMAD) and the Geometric Standard Deviation (gsd) were determined based on OECD guidance document No 39.
- 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 and humidity in air chamber: 18.7 – 21.6 °C, 5.6 – 6.8%

TEST ATMOSPHERE
- Brief description of analytical method used: Sample volumes were measured by means of a dry gas meter. The collected amount of test item in the air sample was measured gravimetrically.
- Samples taken from breathing zone: yes. Samples were drawn from the test atmosphere through a tube mounted in one of the free animal ports of the exposure chamber.

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric
Duration of exposure:
4 h
Concentrations:
1.1 ± 0.04 and 5.2 ± 0.2 mg/L air (analytical concentrations)
3.0 and 7.9 mg/L air (nominal concentrations)
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: Animals were checked for mortality, behavioral signs of distress and effects on respiration at least three times during exposure. Post exposure observations were performed at periodic intervals on the day of exposure (at least two times) and once daily thereafter. Animals were weighed individually on Day 1 (pre exposure), 2, 4 and 8 and 15.
- Necropsy of survivors performed: Yes, all animals were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 - < 5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
1 mg/L: 0/5 males and 1/5 females died approximately two hours after exposure.
5 mg/L: 5/5 males and 5/5 females died or were sacrificed in moribund condition during exposure or within one hour after exposure.
Clinical signs:
other: 1 mg/L: Slow breathing was seen in 1/5 males during exposure. Lethargy, hunched posture, labored respiration and/or piloerection were noted in 5/5 males and 5/5 females after exposure, fully reversible within 24 h. In addition, clonic spasms, muscle twitc
Body weight:
The mean body weight gain shown by the surviving animals at 1 mg/mL over the study period was within the range expected for rats of this strain and age used in this type of study.
Gross pathology:
1 mg/L: Necropsy revealed no abnormalities
5 mg/L: Mucous or gelatinous contents of the stomach in 5/5 males and 5/5 females, dark red foci or dark red discoloration of the thymus in 2/5 males and 2/5 females and dark red discoloration of the mandibular lymph nodes (both sides) in 0/5 males and 2/5 females were noted.

Table 1: Aerodynamic Particle Size Distribution in the Test Atmosphere

Concentration: 1 mg/mL air Sampling Time 1 Sampling Time 2
Stage Cut point
(µm)
Mass sampled
(mg)
Relative mass
(%)
Cumulative mass
(% of total sampled)
Mass sampled
(mg)
Relative mass
(%)
Cumulative mass
(% of total sampled)
1 21 0.06 0.73 99.27 0.06 0.63 99.37
2 15 0.02 0.24 99.03 0.04 0.42 98.95
3 10 0.19 2.3 96.73 0.31 3.25 95.71
4 6 0.94 11.38 85.35 1.25 13.09 82.62
5 3.5 3.32 40.19 45.16 4.02 42.09 40.52
6 2 3.31 40.07 5.08 3.56 37.28 3.25
7 0.9 0.26 3.15 1.94 0.21 2.2 1.05
8 0.5 0.02 0.24 1.69 0.02 0.21 0.84
Back up 0.25 0.14 1.69 0 0.08 0.84 0
MMAD1(mm): 3.4 3.6  
gsd2:     2     1.9  
Concentration: 5 mg/mL air Sampling Time 1 Sampling Time 2
Stage Cut point
(µm)
Mass sampled
(mg)
Relative mass
(%)
Cumulative mass
(% of total sampled)
Mass sampled
(mg)
Relative mass
(%)
Cumulative mass
(% of total sampled)
1 21 0.06 0.74 99.26 0.07 0.67 99.33
2 15 0.01 0.12 99.13 0 0 99.33
3 10 0.4 4.94 94.19 0.45 4.3 95.03
4 6 1.36 16.81 77.38 1.67 15.95 79.08
5 3.5 3.02 37.33 40.05 3.77 36.01 43.08
6 2 2.94 36.34 3.71 3.9 37.25 5.83
7 0.9 0.3 3.71 0 0.52 4.97 0.86
8 0.5 0 0 0 0 0 0.86
Back up 0.25 0 0 0 0.09 0.86 0
MMAD 1(mm): 4.3 3.7  
gsd 2:     1.7     1.8  
1 Mass Median Aerodynamic Diameter; 2 Geometric Standard Deviation      
Interpretation of results:
other: Acute Inhal. 4, H332 according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: Acute Inhal. 4, H332 according to Regulation (EC) No. 1272/2008
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
1 mg/m³
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No. 1907/2006.

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:
20 Jun - 16 Jul 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Oct 2017
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10 - 12 weeks
- Weight at study initiation: 179 - 200 g
- Fasting period before study: yes, during designated procedures
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany). For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 32 - 65
- Air changes (per hr): ten or greater
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Jun 2018 To: 16 Jul 2018
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 7 cm clipped skin of the dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap: The test material was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test material using water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 10 mL/kg bw
Duration of exposure:
24 h
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: Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Animals were weighed individually on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes, all animals
- Other examinations performed: The skin reactions were assessed approximately 24, 48 and 72 hours after the removal of the dressing and test material. Adjacent areas of untreated skin of each animal served as controls.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occurred during the study period.
Clinical signs:
2000 mg/kg bw: Piloerection and hunched posture were noted each in 2/3 females on Day 2. Chromodacryorrhoea (snout and/or left eye) was observed in 2/3 females on the day of administration and thereafter in all females on Day 2. 1/3 females showed scales on the treated skin on Days 4 - 5 and hypothermia on Day 2, respectively.
Body weight:
Body weight gains of all dose groups were within the normal ranges in females during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
- Irritation scores: No erythema and edema were observed in all three animals at the 24-, 48- and 72-h reading time points.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No. 1907/2006.

Additional information

Acute oral toxicity:

N-Ethylcaprolactam was tested for acute oral toxicity according to OECD guideline 423 (acute toxic class method) and in compliance with GLP (Charles River Laboratories, 2018). The test item was applied unchanged (no vehicle) as a single dose administered by oral gavage to female Wistar rats. In stepwise procedure, the dose levels for N-ethylcaprolactam were 2000 mg/kg bw for the first dosing and 300 mg/kg bw for the second and third dosing step. Three animals were used in each step. After administration, the animals were observed for a time period of 14 days to assess general health, body weight gain and mortality. At the end of the observation period and in case of mortality, gross necropsy was performed on all surviving and descendent animals.

Mortality occurred in all animals dosed at 2000 mg/kg bw on the day of administration. At 300 mg/kg bw no deaths were recorded until the end of the observation period. Ante mortem signs comprised tonic spasms, paddling movements, lateral recumbency, gasping, piloerection and hypersensitivity to touch in all animals. At 300 mg/kg bw, hunched posture, piloerection and salivation were noted on Days 1 and/or 2. Body weight gain was not affected throughout the whole study period. Gross pathology revealed no test item-related findings.

Under the tested conditions, the acute oral LD50 in female rats was established to be within the range of 300 - 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg bw. 

Acute inhalation toxicity:

N-Ethylcaprolactam was tested for acute inhalation toxicity according to OECD guideline 403 and in compliance with GLP (Charles River Laboratories, 2019). Each 5 male and 5 female Wistar rats were exposed via nose only to an aerosol of the test substance at target concentrations of 1 and 5 mg/L air for 4 h. At 1 and 5 mg/L, the time-weighted mean actual concentrations were 1.1 ± 0.04 mg/L and 5.2 ± 0.2 mg/L, respectively.The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was 3.4 ± 2.0 µm and 3.6 ± 1.9 µm at 1 mg/L and 4.3 ± 1.7 µm and 3.7 ± 1.8 µm at 5 mg/L. After exposure, the animals were observed for 14 days, including daily observations for clinical signs and mortality, monitoring of individual body weights on Days 1, 2, 4, 8 and 15 and macroscopical examination at scheduled necropsy.

Mortality was observed for one female at 1 mg/L 2 h following exposure. At 5 mg/L, all animals were found dead or sacrificed in moribund condition during exposure or within one hour after exposure. Clinical signs during exposure comprised slow breathing in 1/5 males exposed to 1 mg/L and slow, labored and shallow respiration in all animals exposed to 5 mg/L. After exposure, all animals at 1 mg/L showed lethargy, hunched posture, labored respiration and/or piloerection. In addition, clonic spasms, muscle twitching, flat posture and lateral recumbency were noted for the female animal found dead at 1 mg/L. Surviving animals fully recovered within 24 h following exposure. There was no effect on body weight in the surviving animals at 1 mg/L over the study period. Macroscopical examination at scheduled necropsy revealed no abnormal findings at 1 mg/L. At 5 mg/L, mucous or gelatinous contents of the stomach was observed in 5/5 males and 5/5 females, dark red foci or dark red discoloration of the thymus was noted in 2/5 males and 2/5 females and dark red discoloration of the mandibular lymph nodes was found in 2/5 females.

Based on the experimental results, the acute inhalation LC50 value in male and female rats was established to be greater than 1 mg/L but less than 5 mg/L air.

 

Acute dermal toxicity:

N-Ethylcaprolactam was tested for acute dermal toxicity according to OECD guideline 402 and in compliance with GLP (Charles River Laboratories, 2018). The test item was applied unchanged (no vehicle) to the clipped skin of the dorsal area of the trunk of three female Wistar rats. The skin was exposed for 24 h to a limit dose of 2000 mg/kg bw under semiocclusive conditions. After 24 h of exposure, the treated area of skin was cleaned with water. Skin reactions were assessed 24, 48 and 72 h after exposure. During a 14 day observation period, all animals were observed for general health, body weight changes and mortalities. At study termination, all animals underwent necropsy.

No mortalities were observed throughout the whole study period. No erythema or oedema was noted for any of the animals during observations for irritation in Days 3, 4 and 5. Scaliness of the treated skin was noted for one animal on Days 4 and 5. Piloerection, chromodacryorrhea (snout and/or left eye), hunched posture and/or hypothermia were noted for the animals on Days 1 and/or 2. Body weight gain of all rats was within the normal ranges until termination of the study. Necropsy revealed no substance-related findings.

Under the tested conditions, the acute dermal LD50 in female rats was > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity and acute inhalation toxicity of the test substance meet the criteria for classification as Acute Tox. 4 (H302 and H332) according to Regulation (EC) No. 1272/2008. The available data on acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.