Phosphoric acid, iron(2+) lithium salt (1:1:1)

Endpoint summary

Description of key information

Acute oral toxicity:
LD50 > 2000 mg/kg bw, rat (female), OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF guidelines, Huygevoort (2006)
Acute inhalation toxicity:
LC50 > 3.2 mg/L, rat (male/female), OECD 403, EU Method B.2, EPA OPPTS 870.1300 and JMAFF, Janssen (2007)
Acute dermal toxicity:
LD50 > 2000 mg/kg bw, rat (male/female), OOECD 402, EU Method B.3 and EPA OPPTS 870.1200, Lükenhaus (2012)

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:

3 October 2006 - 13 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines (2000)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 222 - 258 g (Day 1)
- Fasting period before study: yes (food was witheld overnight - for a maximumof 20 hours - prior to dosing until 3-4 hours after administration of the test material)
- Housing: animals were housed in groups of 3 in Macrolon cages furnished withy sterilised sawdust and paper as cage-enrichment.
- Diet: pelleted rodent diet, SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 23.0 °C
- Humidity (%): 41 - 91%
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Route of administration:

oral: gavage

Vehicle:

other: Water (Milli-U)

Details on oral exposure:

The formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.

Doses:

2000 mg/kg (10 mL/kg) bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

STUDY DESIGN
The toxicity of the test material was assessed by stepwise treatment of groups of 3 females. the first group was treated at a dose of 2000 mg/kg. Due to the absence of mortality, the second group of animals was also dosed at 2000 mg/kg.

OBSERVATIONS
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality was observed twice daily. Body weights were recorded on day 1 (pre-administration), 8 and 15. Clinical signs were observed at periodic intervals on the day of dosing and once daily thereafter until day 15.
- Necropsy of survivors performed: yes (descriptions of all internal macroscopic abnormalities were recorded).

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None of the animals died during the study.

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the oral LD50 value of the test material in female Wistar rats was in excess of 2000 mg/kg bw, the highest permissible dose level tested.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF guidelines, following the acute toxic class method.

During the study, the test material was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.

None of the animals died during the study and no clinical signs were noted. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Furthermore, no abnormalities were found at macroscopic post mortem

examination of the animals.

Therefore, under the conditions of the study, the oral LD50 value of the test material in female Wistar rats was in excess of 2000 mg/kg bw, the highest permissible dose level tested.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was conducted under GLP conditions and in accordance with standardised guidelines. The study was assigned a Klimisch score of 1. The supporting study is a guideline study but GLP status cannot be confirmed and hence the supporting study has been assigned a Klimisch score of 2. The quality of the database is good.

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:

15 February 2007 to 15 May 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

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: JMAFF (12 Nousan, Notification No. 8147)

GLP compliance:

yes (incl. QA statement)

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: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 12 weeks
- Housing: prior to expsure animals were housed 5 by sex in Marcolon cages furnished with sterilised sawdust and paper cage enrichment. After the exposure the animals were housed in groups of 5 by sex in labelled stainless steel wire mesh cages.
- Diet: pelleted rodent diet, SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 23.1 °C
- Humidity (%): 42 - 65 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: Milli-U water

Details on inhalation exposure:

TRIAL TEST ATMOSPHERE GENERATION
Trial generations of a test atmosphere revealed that a dry dust aerosol could not be generated at sufficiently high concentrations due to clogging of the aerosol generating equipment by the test material. Trial generations of a test atmosphere with formulations of the test material at concentrations in water were performed. A formulation of 2 g test material in 3 g of water was considered optimal for the 4 -hour exposure of the animals. The mean concentration of 3.2 mg/L achieved during the study was considered to be the highest attainable.

EXPOSURE CHAMBER
The chamber consisted of 3 animal sections with 8 animal ports each. The number of open animal ports was adapted to the air flow in such a way that at each animal port the theoretical air flow was approximately 2.0 L/min, which ensures an adequate oxygen supply to the test animals. The inlet of the test atmosphere was located in the top section and the outlet was located in the bottom section. The direction of the flow of the test atmosphere guaranteed a freshly generated atmosphere for each individual animal.

TEST ATMOSPHERE GENERATION
The test material suspension was placed on a magnetic stirrer fed by means of a peristatic pump to a Hospitak nebuliser type 950 operating at an air pressure of 1.9 bar. The mean air flow under these conditions was 15.5 L/minute. Subsequently the aerosol was passed through the exposure chamber. from the exposure chamber the test atmosphere was passed through a filter before it was released to the exhaust of the fume hood.

NOMINAL CONCENTRATION
The nominal concentration was calculated by dividing the amount of test material used by the volume of pressurised air entering the exposure chamber used for exposure of the animals.

ACTUAL CONCENTRATION
The actual concentration was determined 10 times during the exposure period. Samples were drawn from the test atmosphere through a tube mounted in one of the free animals ports in the middle section of the exposure chamber. Samples were drawn through a glass fiber filter. After sampling the filters were dried by passing 5 litres of room air through the filters. The collected amount of test material in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter.

PARTCILE SIZE CHARACTERISATION
The particle size was characterised twice during the exposure period. the samples were drawn (2 L/min) from the test atmosphere through a tube mounted in one of the free animal ports of the middle section of the exposure chamber. The samples were collected with an 8 stage Marple personal cascade impactor, fiber glass filters and a fiber glass back-up filter. Amounts of test material collected were gravimetrically analysed.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

3.2 ± 1.1 mg/L (mean measured)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality and viability were performed twice daily. Body weights were recorded on days 1 (pre-administration), 8 and 15. Clinical signs were recorded twice on the day of dosing and once daily thereafter.
- Necropsy of survivors performed: yes (all animals were necropsied at the end of the observation period and subject to gross pathological examination)

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.2 mg/L air

Exp. duration:

4 h

Remarks on result:

other: represents the highest test concentration considered to be technically attainable

Mortality:

None of the animals died during the study.

Clinical signs:

other: During and after exposure no clinical signs were noted. No effects on body weight and body weight gain indicative of toxicity were noted.

Body weight:

Between days 1 and 8 slight body weight loss was noted in all males and two females and reduced weight gain was noted in three females. Body weight gain resumed normal values in males and females between day 8 and 15. Weight loss or reduced weight gain during the first days following an acute inhalatory exposure is a common finding hence this finding is not considered to be indicative of test material toxicity.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Test atmosphere concentration

The mean actual concentration was 3.2 ± 1.1 mg/L. The nominal concentration was 23.3 mg/L. The generation efficiency was 15%.

Particle size

The mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined twice. The MMAD was 3.0 and 3.2 µm, respectively and the GSD was 2.1 and 2.0, respectively.

Stability monitoring

During the exposure a gradual decrease of the opacity due to a decrease of test material concentration was noted. For this reason a nebulizer was cleaned at regular intervals, after which the opacity showed an instantaneous increase.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 of the test material was determined to be in excess of 3.2 mg/L, the highest test concentration considered to be technically attainable.

Executive summary:

The acute inhalation toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 403, EU Method B.2, EPA OPPTS 870.1300 and JMAFF.

During the study the test material was administered by nose-only inhalation, for 4 hours, to one group of five male and five female Wistar rats, followed by a 14 -day observation period. Animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice.

The mean actual concentration was 3.2 ± 1.1 mg/L. The nominal concentration was 23.3 mg/L. The generation efficiency was 15%.

The mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined twice. The MMAD was 3.0 and 3.2 µm, respectively and the GSD was 2.1 and 2.0, respectively.

Under the conditions of the study no mortality occurred and no clinical signs were noted. No effects on body weight and body weight gain indicative of toxicity were noted. Furthermore, no abnormalities were found at macroscopic post mortem examination.

The acute inhalation LC50 of the test material was determined to be in excess of 3.2 mg/L, the highest test concentration considered to be technically attainable.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

3.2 mg/m³ air

Quality of whole database:

The key study was conducted under GLP conditions and in accordance with standardised guidelines. The study was assigned a Klimisch score of 1. The supporting study is a guideline study but GLP status cannot be confirmed and hence the supporting study has been assigned a Klimisch score of 2. The quality of the database is good.

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:

22 May 2012 to 27 June 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

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. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

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

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks (males); 12 - 14 weeks (females)
- Weight at study initiation: 240 - 262 g (amles); 206-223 g (females)
- Fasting period before study: no data
- Housing: animals were individually housed in IVC cages, type III H furnished with Altromin saw fibre bedding
- Diet: ALTROMIN 1324 maintenance diet for rats and mice (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Vehicle:
TEST SITE
- Area of exposure: back
- % coverage: ca 10 % of body surface
- Type of wrap if used: semiocclusive gauze + adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at end of exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 100 %
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test material was used as supplied. In order to ensure good skin contact it was moistened with aqua ad injectionem.

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 weighed on days 1 (prior to application), 8 and 15. A clinical examination was made several time of the day of dosing; thereafter, animals were observed daily.
- Necropsy of survivors performed: yes, macroscopic

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

other: No signs of toxicity were noted during the study.

Gross pathology:

Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. these were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals.

Other findings:

No erythema or oedema was noted on any animal during the study.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200.

During the study, five male and five female rats received semi-occlusive dermal applications of 2000 mg/kg bw of test material. The exposure duration was 24 hours. The animals were observed for mortality, clinical signs, body weight changes and local reactions for 14 days after which time they were sacrificed and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, no clinical signs were observed and the body weight development of all male and female animals was within the expected range. Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. These were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals. No erythema or oedema was noted on any animal during the study.

It was therefore concluded that the acute dermal LD50 of the test material is in excess of 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was conducted under GLP conditions and in accordance with standardised guidelines. The study was assigned a Klimisch score of 1. The supporting study is a guideline study but GLP status cannot be confirmed and hence the supporting study has been assigned a Klimisch score of 2. The quality of the database is good.

Additional information

Acute toxicity oral:

In the key study, the acute oral toxicity of the test material was investigated under GLP conditions and in accordance with the standardised guidelines OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100 and JMAFF guidelines, following the acute toxic class method.

During the study, the test material was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg bw. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.

None of the animals died during the study and no clinical signs were noted. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Furthermore, no abnormalities were found at macroscopic post mortem examination of the animals.

Therefore, under the conditions of the study, the oral LD50 value of the test material in female Wistar rats was in excess of 2000 mg/kg bw, the highest permissible dose level tested.

This was selected as the study since it was conducted under GLP conditions and in accordance with standardised guidelines.

In the supporting study, the acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 following the standard acute method.

During the study, the test material was administered by oral gavage to four groups of five male Sprague-Dawley rats at dose levels of 1000, 2150, 4640 and 10000 mg/kg bw and to four groups of five female Sprague Dawley rats at dose levels of 2150, 4640, 10000 and 21500 mg/kg bw. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice following a 14 day observation period.

All of the females dosed at 2150 mg/kg bw survived; there were 2, 5 and 5 mortalities at dose levels of 4640, 10000 and 21500 mg/kg bw, respectively. All of the males dosed at 1000 and 2150 mg/kg bw survived; there were 4 and 5 mortalities at dose levels of 4640 and 10000 mg/kg bw, respectively. Clinical signs of toxicity such as black mucus, nosebleed, bloody tears were noted in female rats at dosews of 4640, 10000 and 21500 mg/kg and male rats at doses of 4640 and 10000 mg/kg bw. Animals that died during the study were found to have reduced bodyweights compared to those recorded at study initiation. No abnormal necropsy findings occurred in any test animal which could be suspected to be due to the test material.

Therefore, under the conditions of the study, the oral LD50 value of the test material in male and female Sprague-Dawley rats was determined to be 3690 mg/kg bw and 5010 mg/kg bw, respectively.

 

Acute inhalation toxicity:

In the key study, the acute inhalation toxicity of the test material was investigated under GLP conditions and in accordance with the standardised guidelines OECD 403, EU Method B.2, EPA OPPTS 870.1300 and JMAFF.

During the study the test material was administered by nose-only inhalation, for 4 hours, to one group of five male and five female Wistar rats, followed by a 14 -day observation period. Animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice.

The mean actual concentration was 3.2 ± 1.1 mg/L. The nominal concentration was 23.3 mg/L. The generation efficiency was 15%.

The mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined twice. The MMAD was 3.0 and 3.2 µm, respectively and the GSD was 2.1 and 2.0, respectively.

Under the conditions of the study no mortality occurred and no clinical signs were noted. No effects on body weight and body weight gain indicative of toxicity were noted. Furthermore, no abnormalities were found at macroscopic post mortem examination.

The acute inhalation LC50 of the test material was determined to be in excess of 3.2 mg/L, the highest test concentration considered to be technically attainable.

This was selected as the study since it was conducted under GLP conditions and in accordance with standardised guidelines.

In the supporting study, the acute inhalation toxicity of the test material was investigated in accordance with the standardised guideline OECD 403.

During the study the test material was administered by nose-only inhalation, for 4.5 hours, to one group of five male and five female Sprague-Dawley rats, followed by a 14 -day observation period. Animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice.

The actual concentration was 5153.3 ± 131.1 mg/m³. The mean mass aerodynamic diameter (MMAD) was 5.14 µm, and the GSD was 2.32.

Under the conditions of the study no mortality occurred and no clinical signs were noted. No effects on body weight ndicative of toxicity were noted. Furthermore, no abnormalities were found at macroscopic post mortem examination.

The acute inhalation LC50 of the test material was therefore determined to be in excess of 5000 mg/m³.

Acute dermal toxicity:

In the key study, the acute dermal toxicity of the test material was investigated under GLP conditions and in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200.

During the study, five male and five female rats received semi-occlusive dermal applications of 2000 mg/kg bw of test material. The exposure duration was 24 hours. The animals were observed for mortality, clinical signs, body weight changes and local reactions for 14 days after which time they were sacrificed and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, no clinical signs were observed and the body weight development of all male and female animals was within the expected range. Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. These were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals. No erythema or oedema was noted on any animal during the study.

It was therefore concluded that the acute dermal LD50 of the test material is in excess of 2000 mg/kg bw.

This was selected as the study since it was conducted under GLP conditions and in accordance with standardised guidelines.

In the supporting study the acute dermal toxicity of the test material was investigated in accordance with the standardised guideline OECD 402.

During the study, five male and five female rats received semi-occlusive dermal applications of 2000 mg/kg bw of test material. The exposure duration was 24 hours. The animals were observed for mortality, clinical signs, body weight changes and local reactions for 14 days after which time they were sacrificed and subjected to gross necropsy.

Under the conditions of the study, none of the animals died, no clinical signs were observed and the body weight development of all male and female animals was within the expected range. No specific gross pathological changes were recorded for any other animals.

It was therefore concluded that the acute dermal LD50 of the test material is in excess of 2000 mg/kg bw.

Justification for classification or non-classification

The substance does not fulfil the classification criteria for acute toxicity according to European Regulation (EC) No 1272/2008.