Neodymium oxide

Endpoint summary

Description of key information

ACUTE TOXICITY: VIA THE ORAL ROUTE
All three studies available for this endpoint report an acute oral LD50 in the rat of >5000 mg/kg bodyweight. 
ACUTE TOXICITY: VIA INHALATION ROUTE
The 4 hour LC50 in the rat was > 4.98 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

data not available

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Cited as Directive 79/831 Annex V part B

Deviations:

no

GLP compliance:

yes

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:
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 160 - 200 g (males), 140 - 180 g (females)
- Fasting period before study: yes (16 - 17 hr)
- Housing: 2 or 5 animals in plastic cages (365 x 225 x 180 mm) containing a sterilised and vacuum-cleaned sawdust litter
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 1.5 °C
- Humidity: 55 ± 15 %
- Air changes: 10 per hour
- Photoperiod: data not available

In-life dates: data not available

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 g test item / 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

0, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 1 h, 2 h, 4 h, and on days 1, 2, 4, 7 and 14 after treatment
> weighing: one day before treatment, and on days 0, 7 and 14 after treatment
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was used

Preliminary study:

3 doses (1000, 2500 and 5000 mg/kg bw) were tested. The vehicle was water. 2 males and 2 females were used per dose. Mortality checks were performed at 1, 2, 4 h, and then on days 1, 2, 4, 7 and 14.
No mortality was observed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats dosed with 0 or 5000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed in rats dosed at 0 or 5000 mg/kg bw.

Gross pathology:

No gross abnormalities were observed at necropsy.

Other findings:

- Organ weights, Histopathology: not performed
- Potential target organs: no abnormality at necropsy
- Other observations: none

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 (males and females) was >5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.

Executive summary:

An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline EU Method B.1.

Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in aqueous solution at a dose of 5000 mg/kg bw and observed for 14 days.

No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.

The oral LD50 (males and females) was >5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

6 November 1990 - 20 November 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

other: FHSA 16 CFR 1500.3

Deviations:

no

GLP compliance:

not specified

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
- Age at study initiation: Young adult
- Weight at study initiation: Males 191 - 214 g; females 194 - 208 g
- Fasting period before study: Yes, approximately 18 hours
- Housing: Individually housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum tap water supplied by automatic watering system
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C

IN-LIFE DATES: From: To: 6 November 1990 - 20 November 1990

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

Vehicle:
- Concentration in vehicle: 50 % w/w solution

Doses:

single dose of 5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

Individual doses were calculated based on the fasting weights, taking into account the specific gravity of the test material. Each rat was then individually and singly dosed by gavage using a calibrated syringe and a stainless steel intubation needle.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 1, 2 and 24 hours post-dosing and at least once daily thereafter for signs of gross toxicity and mortality. Bodyweights were recorded initially and at termination (day 14). Animals were euthanised by CO2 inhalation.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality.

Clinical signs:

other: Several animals had a hunched posture within the first two hours after dosing but recovered. There were no signs of adverse pharmacologic effects or abnormal behaviour.

Gross pathology:

There were no signs of gross toxicity.

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not classified based on the results of this acute oral toxicity study (Oral LD50 Combined male/female > 5000 mg/kg bw) in accordance with EU criteria.

Executive summary:

An acute oral toxicity limit test was conducted to assess the test material in accordance with FHSA guideline 16 CFR 1500.3.

Groups of fasted Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in distilled water as a 50 % w/w solution at a dose of 5000 mg/kg bw and observed for 14 days.

No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.

The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the material is not classified for acute oral toxicity according to EU criteria on the basis of this study.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Valid with restrictions. This is peer reviewed data where the test methodology and identity of the substance have been evaluated, and a reliable and representative value for the endpoint has been selected. No information on GLP status or test guideline followed is available.

Qualifier:

no guideline available

Principles of method if other than guideline:

Handbook data does not specify the method. Data from peer reviewed source.

GLP compliance:

not specified

Species:

rat

Route of administration:

oral: unspecified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in the rat was >5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on this result according to EU criteria.

Executive summary:

In a peer reviewed handbook, where the test methodology and identity of the substance have been evaluated and a reliable and representative value for the endpoint has been selected, the oral LD50 in the rat was listed as > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity according to EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Two supporting studies are available. The first was conducted in accordance with the standardised FHSA guideline 16 CFR 1500.3. It was well reported and adhered to sound scientific principles. It was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997).
The second supporting study is handbook data and as such has been awarded a reliability score of 2 in accordance with the criteria of Klimisch (1997).

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:

1 November 2012 - 21 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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:

TEST ANIMALS
- Strain: RccHan:WIST
- Age at study initiation: approximately 8 - 12 weeks
- Weight at study initiation: 200 - 265 g
- Fasting period before study: no
- Housing: The animals were housed in groups of up to three by 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 (e.g. ad libitum): With the exception of the exposure period, free access to food was allowed.
- Water (e.g. ad libitum): ad libitum with the exception of the exposure period.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15 per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled to give twelve hours continuous light and twelve hours darkness.

IN-LIFE DATES: From: 1 November 2012 To: 21 November 2012

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

clean air

Details on inhalation exposure:

TEST MATERIAL TREATMENT
In order to facilitate aerosolisation and reduce particle size, the test material was first ground using a Retsch Planetary Ball Mill (Retsch (UK) Ltd., Leeds, UK) before being ground further in an IKA mini grinder prior to use.

ATMOSPHERE GENERATION
A dust atmosphere was produced from the test material using an 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.
A particle separator was introduced before the aerosol entered the exposure chamber in order to remove large particles and thereby increase the inhalable portion of the generated aerosol.
Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the SAG 410.
The cylindrical exposure chamber had a volume of approximately 30 litres (dimensions: 28 cm diameter x 50 cm high). The concentration within the chamber was controlled by adjusting the test material feed rate from the SAG 410. The extract from the exposure chamber passed through a ‘scrubber’ trap and was connected with a high efficiency filter to a metered exhaust system. The chamber was maintained under negative pressure.

Prior to the start of the study, test material atmospheres were generated within the exposure chamber. During this characterisation period test material input rates and the generation system were varied in order to achieve the required atmospheric conditions.


EXPOSURE PROCEDURE
Prior to the day of exposure each rat was acclimatised (for approximately 2 hours) to a tapered polycarbonate restraining tube. During the day of exposure, each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber ‘O’ ring.
A target concentration of 5.0 mg/L was used for the exposure. The mean achieved concentration was 99.6 % of target.


EXPOSURE CHAMBER TEMPERATURE AND RELATIVE HUMIDITY
The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd, Beds., UK) located in a vacant port in the animals’ breathing zone of the chamber and recorded every thirty minutes.


EXPOSURE CHAMBER OXYGEN CONCENTRATION
Oxygen levels within the exposure chamber were measured by an electronic oxygen analyser (Servomex (UK) Ltd, Crowborough, East Sussex) located in a port in the animals' breathing zone. The test atmosphere was generated to contain at least 19 % oxygen.
The MMAD was 3.06 µm, resulting in an inhalable fraction (% <4 µm) of 61.9. The geometric standard deviation was 2.44.


EXPOSURE CHAMBER ATMOSPHERE CONCENTRATION
The actual chamber concentration was measured at regular intervals during the exposure period. The gravimetric method used glass fibre filters placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals’ breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump.
Each filter was weighed before and after sampling in order to calculate the weight of collected test material. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration.
The nominal chamber concentration was calculated by dividing the mass of test material used by the total volume of air passed through the chamber.
The nominal concentration is 308 % of the actual mean achieved atmosphere concentration and shows that keeping the aerosol airborne was relatively straightforward.


PARTICLE SIZE DISTRIBUTION
The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period using a Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK). This device consisted of six impactor stages (8.6, 5.5, 3.8, 1.7, 0.86 and 0.41 µm cut points) with stainless steel collection substrates and a back up glass fibre filter, housed in an aluminium sampler. The sampler was temporarily sealed in a sampling port in the animals’ breathing zone and a suitable, known volume of exposure chamber air was drawn through it using a vacuum pump.
The collection substrates and backup filter were weighed before and after sampling and the weight of the test material, collected at each stage, calculated by the difference.
The mean amount for each stage was used to determine the cumulative amount below each cut-off point size. In this way, the proportion (%) of aerosol less than 8.6, 5.5, 3.8, 1.7, 0.86 and 0.41 µm was calculated.
The resulting values were converted to probits and plotted against Log10 cut-point size. From this plot, the Mass Median Aerodynamic Diameter (MMAD) was determined (as the 50 % point) and the geometric standard deviation was calculated. In addition the proportion (%) of aerosol less than 4 µm (considered to be the inhalable fraction) was determined.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The test atmosphere was sampled seventeen times during the exposure period and the actual concentration of the test material calculated.

Duration of exposure:

4 h

Concentrations:

4.98 mg/L (maximum technically achievable concentration)

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 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 up to 14 days. Any evidence of overt toxicity was recorded at each observation.
- Frequency of observations and weighing: Individual bodyweights were recorded on arrival, prior to treatment on the day of exposure and on Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes. At the end of the 14 day observation period the animals were killed by intravenous overdose of sodium pentobarbitone. All animals were subjected to a full external and internal examination, and any macroscopic abnormalities were recorded. The respiratory tract was subjected to a detailed macroscopic examination for signs of irritancy or local toxicity.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4.98 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: maximum technically achievable concentration

Mortality:

There was no mortality during the study.

Clinical signs:

other: In addition to the observations considered to be due to the restraint procedure (such as hunched posture, pilo-erection, wet fur), increased respiratory rate was noted in all animals on removal from the chamber and one hour post-exposure. One day after ex

Body weight:

All animals exhibited slight bodyweight losses on the first day post-exposure. All animals exhibited reasonable bodyweight gains during the remainder of the observation period.

Gross pathology:

No macroscopic abnormalities were detected at necropsy.

Table 1 Exposure Chamber Atmosphere Concentrations

Duration of Exposure (minutes)	Net Weight of Sample (mg)	Volume of Air Sampled (L)	Chamber Flow Rate (L/min)	Atmosphere Concentration (mg/L)
5	9.34	2	60	4.67
15	9.76	2	60	4.88
31	10.41	2	60	5.21
45	10.04	2	60	5.02
60	10.42	2	60	5.21
75	10.15	2	60	5.08
90	9.78	2	60	4.89
105	9.94	2	60	4.97
120	10.10	2	60	5.05
135	10.23	2	60	5.12
150	8.67	2	60	4.34
165	10.17	2	60	5.09
180	10.06	2	60	5.03
195	10.06	2	60	5.03
210	10.06	2	60	5.03
225	10.27	2	60	5.14
237	9.92	2	60	4.96

Mean achieved atmosphere concentration: 4.98 mg/L (standard deviation 0.21)

 

Nominal Concentration

-Test material used: 239 g

-Air flow: 60 L/min

-Total generation time: 259 minutes*

-Nominal concentration: 15.4 mg/L

 

*Test atmospheres were generated for a total of 19 minutes prior to animal insertion to ensure that the test material concentration was being achieved.

 

Table 2 Particle Size Distribution - Cascade Impactor Data

Impactor Stage Number	Cut Point (µm)	Amount Collected (mg) Per Sample Number			Mean Amount Collected (mg)
		1	2	3
3	8.6	0.20	0.28	0.28	0.25
4	5.5	0.29	0.61	0.47	0.46
5	3.8	0.90	1.26	1.01	1.06
6	1.7	0.73	1.05	0.92	0.90
7	0.86	0.19	0.20	0.21	0.20
8	0.41	0.07	0.15	0.09	0.10
Back-up filter	<0.41	0.19	0.08	0.11	0.13

Total mean amount of test material collected: 3.10 mg

 

Table 3 Particle Size Distribution - Calculation

Cut Point (µm)	Log10 Cut Point	Mean Cumulative Amount Less Than Cut Point
		(mg)	(%)	Probit
8.6	0.935	2.85	91.9	6.40
5.5	0.740	2.39	77.1	5.74
3.8	0.580	1.33	42.9	4.82
1.7	0.230	0.43	13.9	3.91
0.86	-0.066	0.23	7.42	3.56
0.41	-0.387	0.13	4.19	3.27

MMAD: 3.06 µm

Geometric standard deviation: 2.44

Predicted amount <4 µm: 61.9 %

 

Table 4 Individual Bodyweights

Animal Number and Sex	Bodyweight (g) on Day:						Increment (g) During Days:
	-7	0	1	3	7	14	-7 to 0	0 to 1	1 to 3	3 to 7	7 to 14
1 Male	225	265	260	271	287	311	40	-5	11	16	24
2 Male	222	265	263	272	284	315	43	-2	9	12	31
3 Male	206	235	232	244	260	286	29	-3	12	16	26
4 Female	200	211	207	213	216	221	11	-4	6	3	5
5 Female	195	201	200	203	205	210	6	-1	3	2	5
6 Female	203	216	211	219	222	233	13	-5	8	3	11

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The 4 hour LC50 was determined to be >4.98 mg/L, therefore the test material requires no classification under the conditions of this study in accordance with EU criteria.

Executive summary:

An acute inhalation study was conducted to assess the toxicity potential of the test material in accordance with the standardised guideline OECD 436.

Male and female RccHan:WIST strain rats (3 per sex) were exposed (nose only) for 4 hours to a dust atmosphere containing the test material at a mean concentration of 4.98 mg/L, with a MMAD of 3.06 µm.

Following exposure, the animals were observed for 14 days for signs of mortality and toxicity. At the end of the observation period, all animals were subjected to necropsy.

No deaths occurred and no clinical signs were observed throughout the study and the 4 hour LC50 was therefore determined to be >4.98 mg/L. The test material requires no classification under the conditions of this study in accordance with EU criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The key study was conducted in line with GLP and in accordance with the standardised guideline OECD 436. It was well reported and adhered to sound scientific principles. It was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997).

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In accordance with the column 2 adaptation of column 1, REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.3) is not considered scientifically justified as the oral and inhalation exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern. Furthermore, dermal exposure of the substance is considered unlikely.

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity: via the oral route

The key study is an acute oral toxicity limit test conducted in accordance with the standardised guideline EU Method B.1.

Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in aqueous solution at a dose of 5000 mg/kg bw and observed for 14 days.

No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.

The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.

 

The first supporting study is an acute oral toxicity limit test conducted in accordance with the FHSA guideline 16 CFR 1500.3.

Groups of fasted Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in distilled water as a 50 % w/w solution at a dose of 5000 mg/kg bw and observed for 14 days.

The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the material is not classified for acute oral toxicity according to EU criteria on the basis of this study.

 

The second piece of supporting information is handbook data. This quotes the oral LD50 in the rat as > 5000 mg/kg bw and the test material requires no classification for acute oral toxicity based on this result according to EU criteria.

 

Acute toxicity: via the inhalation route

The key acute inhalation study was conducted in accordance with the standardised guideline OECD 436.

Male and female RccHan:WIST strain rats (3 per sex) were exposed (nose only) for 4 hours to a dust atmosphere containing the test material at a mean concentration of 4.98 mg/L (maximum achievable concentration), with a MMAD of 3.06 µm.

Following exposure, the animals were observed for 14 days for signs of mortality and toxicity. At the end of the observation period, all animals were subjected to necropsy.

No deaths occurred and no clinical signs were observed throughout the study and the 4 hour LC50 was therefore determined to be > 4.98 mg/L. The test material requires no classification under the conditions of this study in accordance with EU criteria.

Justification for selection of acute toxicity – oral endpoint
The key study was conducted in line with GLP and in accordance with the standardised guideline EU Method B.1. It was well reported and adhered to sound scientific principles. It was awarded a reliability score of 1 in accordance with the criteria of Klimisch (1997). Hazelton (1984) was selected as key above Shapiro (1990), on the basis that only Hazelton (1984) was conducted in accordance with an EU Test Method. Both studies give the same end result.

Justification for selection of acute toxicity – inhalation endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
In accordance with the column 2 adaptation of REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.3) is not considered scientifically justified as the oral and inhalation exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern. Furthermore, dermal exposure of the substance is considered unlikely.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for acute oral or acute inhalation toxicity.