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REACH

Reaction mass of Ammonium bisethanedioato bisaquo niobate(V) (anhydrous form) and Ammonium hydrogen ethanedioate ethanedioic acid (anhydrous form)

EC number: 939-559-9 | CAS number: -

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Oral (OECD 423), rat (m/f): LD50 = 300-2000 mg/kg bw 
Inhalation (OECD 403), rat (m/f): LC50 > 5.10 mg/L
Dermal (OECD 402), rat (m/f): LD50 > 4000 mg/kg bw

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:: 25 Oct 2006 - 09 Nov 2006
Reliability:: 2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:: guideline study with acceptable restrictions
Remarks:: No necropsy performed; not conducted in compliance with GLP; only limited information
Qualifier:: according to guideline
Guideline:: OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:: (adopted 17 Dec 2001)
Deviations:: yes
Remarks:: (no necropsy was performed and no details on test material purity given)
GLP compliance:: no
Test type:: acute toxic class method
Limit test:: no
Species:: rat
Strain:: Wistar
Sex:: male/female
Details on test animals or test system and environmental conditions:: TEST ANIMALS
- Fasting period before study: yes, 12 h pre-dosing until 3 h post-dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 69
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:: oral: gavage
Vehicle:: water
Doses:: 2000 and 300 mg/kg bw
No. of animals per sex per dose:: - 2000 mg/kg bw: 3 females
- 300 mg/kg bw: 3 males and 3 females
Control animals:: other: not required
Details on study design:: - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 7 and 14
- Necropsy of survivors performed: no
: Key result
Sex:: male/female
Dose descriptor:: LD50
Effect level:: 300 - 2 000 mg/kg bw
Based on:: test mat.
Mortality:: All 3 females treated with 2000 mg/kg bw died on the first day post-dosing.
There was no mortality observed in any of the males or females treated with 300 mg/kg bw throughout the study period.
Clinical signs:: other: 2/3 females dosed with 2000 mg/kg bw showed prostration and ataxia before death. Animals of the 300 mg/kg bw dose groups did not show any signs of toxicity throughout the study period.
Interpretation of results:: Category 4 based on GHS criteria
Conclusions:: CLP: Acute Oral 4, H302

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 (reliability 2). The information is suitable for hazard assessment leading to an endpoint conclusion and is therefore sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, 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:: 20 Feb 2014 - 19 Mar 2014
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study
Qualifier:: according to guideline
Guideline:: OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:: no
GLP compliance:: yes
Test type:: standard acute method
Limit test:: yes
Species:: rat
Strain:: Sprague-Dawley
Sex:: female
Details on test animals or test system and environmental conditions:: TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: males 242-267 g; females 170-199 g
- Housing: singly housing in suspended stainless steel perforated bottom caging; enrichment (e.g., toy) was placed in each cage; litter paper was placed beneath the cage and was changed at least three times per week
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016, ad libitum, except during the exposure
- Water: Filtered tap water was supplied ad libitum, except during exposure
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 45-55
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:: inhalation: dust
Type of inhalation exposure:: nose only
Vehicle:: clean air
Details on inhalation exposure:: GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose Only Inhalation Chamber, ADG Developments LTD
- Exposure chamber volume: 28 L
- Method of holding animals in test chamber: Animals were individually housed in polycarbonate holding tubes which seal to the chamber with an “O” ring during exposure.
- Source and rate of air: Approx. 60.0 liters per minute (Lpm) of filtered generator air was supplied by an air compressor (Powerex Model: SES050822).
- Method of conditioning air: Mass Flow Controller (Omega, Model # FMA-5527)
- System of generating particulates/aerosols: The test substance was aerosolized using a Jet-Mill (Fluid Energy Jet-Mill Serial #J2724E). Prior to aerosolization, the test substance was ground in a coffee mill (Cuisinart, Model #DCG-20N).
- Method of particle size determination: An eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere.
- Temperature, humidity, pressure in air chamber: The exposure chamber temperature and relative humidity range during exposure were 20ºC and 22-24%, respectively.

TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Samples were collected using 37 mm glass fiber filters (WhatmanTM GF/B) in a filter holder attached by ¼ inch Tygon® tubing to a vacuum pump (GAST, Model #1531-107B-G557X). Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. The collections were carried out for 1 minute at airflows of 4.0 Lpm. Sample airflows were measured using a Mass Flow Controller (Aalborg, Model #GFC-17).
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: An eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals at two intervals. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined graphically using two-cycle logarithmic probit axes.
Analytical verification of test atmosphere concentrations:: yes
Duration of exposure:: 4 h
Concentrations:: 5.1 mg/L
No. of animals per sex per dose:: 5
Control animals:: no
Details on study design:: - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality during the exposure period. The animals were examined for signs of gross toxicity, and behavioral changes upon removal from the exposure tube and at least once daily thereafter for 14 days or until death occurred. Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 1, 3, 7, and 14 (terminal) or after death.
- Necropsy of survivors performed: yes. Surviving rats were euthanized via CO2 inhalation on Day 14. Gross necropsies were performed on all decedents and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Statistics:: Statistical analysis was limited to the calculation of the mean and standard deviation.
: Key result
Sex:: female
Dose descriptor:: LC50
Effect level:: < 5.1 mg/L air (analytical)
Based on:: test mat.
Exp. duration:: 4 h
: Key result
Sex:: male
Dose descriptor:: LC50
Effect level:: > 5.1 mg/L air (analytical)
Based on:: test mat.
Exp. duration:: 4 h
: Key result
Sex:: male/female
Dose descriptor:: LC50
Effect level:: > 5.1 mg/L air (analytical)
Based on:: test mat.
Exp. duration:: 4 h
Mortality:: One male and three females died within seven days of exposure to the test atmosphere. Prior to death, the animals were hypoactive and exhibited abnormal respiration and/or ano-genital staining.
Clinical signs:: other:
Body weight:: Although all animals lost weight through Day 3, the animals gained body weight during Days 7 to 14. However, two of the survivors did not surpass their initial body weights by the end of the 14-day observation period.
Gross pathology:: Gross necropsy of the decedents revealed discoloration of the lungs, distention of the stomach, discoloration of the liver and/or distention of the intestines. No gross abnormalities were noted for any of the surviving animals when necropsied at the conclusion of the 14-day observation period.
Interpretation of results:: other: Irritating to the respiratory tract according to Regulation(EC) No. 1272/2008
Conclusions:: CLP: STOT Single Exp. 3, H335

Endpoint conclusion

Endpoint conclusion:: adverse effect observed
Dose descriptor:: discriminating conc.
Value:: 5 100 mg/m³ air
Quality of whole database:: The available information comprises an adequate and reliable study (reliability 1). The information is suitable for hazard assessment leading to an endpoint conclusion and is therefore sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, 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:: 25 Oct 2006 - 08 Nov 2006
Reliability:: 2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:: guideline study with acceptable restrictions
Remarks:: Test site not covered, no necropsy performed; not conducted in compliance with GLP; only limited information.
Qualifier:: according to guideline
Guideline:: OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:: (adopted 24 Feb 1987)
Deviations:: yes
Remarks:: (test site was not covered, ingestion of test material was prevented by complete immobilisation of animals, no necropsy was performed, no details on test material purity given)
GLP compliance:: no
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:: ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 69
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:: open
Vehicle:: water
Details on dermal exposure:: TEST SITE
- Area of exposure: dorsal area
- % coverage: 10% of total body surface

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: no
- For solids, paste formed: yes

OTHER
- Approximately 24 hours before the test, the dorsal hair of animals was removed by cutting and scraping.
- To keep the product in contact with the animals' skin and avoid ingestion or inhalation, the animals were housed individually in small boxes, in order to hinder any movement of animals.
Duration of exposure:: 24 h
Doses:: 4000 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: Days 1, 7 and 14
- Necropsy of survivors performed: no
: Key result
Sex:: male/female
Dose descriptor:: LD50
Effect level:: > 4 000 mg/kg bw
Based on:: test mat.
Mortality:: No mortality occurred throughout the study period.
Clinical signs:: other: There were no clinical signs noted in any of the animals throughout the study period.
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
Dose descriptor:: discriminating dose
Value:: 4 000 mg/kg bw
Quality of whole database:: The available information comprises an adequate and reliable study (reliability 2). The information is suitable for hazard assessment leading to an endpoint conclusion and is therefore sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

Acute Toxicity: via oral route

A reliable key acute oral toxicity study with Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate is available, conducted according to OECD test guideline 423 (acute toxic class method), but not in compliance with GLP (CBMM Europe BV, Key, 2006, AOT). A first group of 3 female Wistar rats received the test item dissolved in water at a dose of 2000 mg/kg bw via gastric intubation. All animals died on the first day post-dosing, two of them showing prostration and ataxia before death. Consequently, a second group consisting of 3 males and 3 females received the test item at a dose of 300 mg/kg bw. There was no mortality observed in any of the males or females treated in this dose group, and no signs of toxicity were noted in any of these animals throughout the study period. Body weight gain in animals dosed with 300 mg/kg bw was as expected. The LD50 is therefore concluded to be in the range of 300-2000 mg/kg bw for both males and females under the conditions of this test.

Acute Toxicity: via inhalation route

A reliable key acute inhalation toxicity study with Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate is available, conducted according to OECD test guideline 403, and in compliance with GLP (CBMM Europe BV, Key, 2014, AIT). Ten healthy Sprague Dawley rats (5 per sex) were exposed to the test atmosphere for 4 hours via the inhalation (nose-only exposure) route. Chamber concentration and particle size distributions of the test substance were determined periodically during the exposure period. The gravimetric chamber concentration was 5.10 mg/L. The average mass median aerodynamic diameter (MMAD) was estimated to be 2.93 µm based on graphic analysis of the particle size distribution. The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days following exposure or until death occurred. Body weights were recorded prior to exposure (initial)and again on Days 1, 3, 7, and 14 (terminal) or after death. Necropsies were performed on all animals. One male and three females died within seven days of exposure to the test atmosphere. Prior to death, the animals were hypoactive and exhibited abnormal respiration and/or ano-genital staining. Following exposure, all surviving animals were hypoactive and exhibited abnormal respiration. In addition, several survivors exhibited ano-genital staining, ocular discharge, facial staining, and/or nasal discharge. Although all animals lost weight through Day 3, the animals gained body weight during Days 7 to 14. However, two of the survivors did not surpass their initial body weights by the end of the 14-day observation period. Gross necropsy of the decedents revealed discoloration of the lungs, distention of the stomach, discoloration of the liver and/or distention of the intestines. No gross abnormalities were noted for any of the surviving animals when necropsied at the conclusion of the 14-day observation period.

Under the experimental conditions of this study, the acute inhalation LC50 of the test substance is greater than 5.10 mg/L in male rats and less than 5.10 mg/L in female rats. The combined acute inhalation LC50 for both sexes is greater than 5.10 mg/L.

It can be concluded that the deaths are contributed to local corrosive effects to the respiratory tract rather than to systemic toxicity. None of the observations indicate systemic toxicity, but observations such as irregular breathing, rales, nasal discharge, ocular discharge, gasping, etc., as well as gross necropsy findings (red lungs) are commonly seen in animals suffering from local irritating/corrosive effects to the respiratory tract. Therefore, as local corrosive effects are generally not sex specific, using the combined LC50 for the human health hazard assessment is justified.

Acute Toxicity: via dermal route

A reliable key acute dermal toxicity study with Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate is available, conducted in principle according to OECD test guideline 402 (standard acute method), but not in compliance with GLP (CBMM Europe BV, Key, 2006, ADT). A group of 5 Wistar rats per sex were applied the test item dissolved in water at a dose of 4000 mg/kg bw on the dorsal area of the trunk. The treated area covered approximately 10% of the total body surface. The test site was not covered following treatment, but the animals were housed individually in small boxes, in order to hinder any movement of animals and to keep the product in contact with the animals’ skin and avoid ingestion or inhalation. 24 h post-dosing, the test item was removed and the animals were observed for the following 14 days. No mortality occurred and no clinical signs were noted in any of the animals throughout the study period. There were no effects of toxicological relevance noted on body weight gain. The LD50 was concluded to be > 4000 mg/kg bw for both males and females under the conditions of this test.

Justification for classification or non-classification

The available data are reliable and suitable for classification. Based on these data, Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate meets the criteria to be classified for acute oral toxicity (Cat 4, H302) according to EC/1272/2008. Furthermore, based on expert judgement a labelling as STOT SE Cat 3 (H335) is warranted, because of the severe local effects in the respiratory tract of the animals which led to mortality in the acute inhalation toxicity study in combination with the facts that Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dihydrate is corrosive to eyes (mucous membranes) and the pH in aqueous solution is 0.4.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Sample Number	Time of Sample (hour)	Mass Collected (mg)	Airflow Sampled (Lpm)	Collection Time (min)	Chamber Concentration (mg/L)
1	0.5	22.2	4	1	5.55
2	1	17.4	4	1	4.35
3	2	20.6	4	1	5.15
4	2.5	21.1	4	1	5.28
5	3.5	20.6	4	1	5.15
6	3.75	20.5	4	1	5.13
Average ± Standard Deviation					5.10±0.40

Sample No.	Time of Sample (hours)	Collection Time (minutes)	Mass Median Aerodynamic Diameter¹ (µm)	Geometric Standard Deviation
1	1.5	1	2.80	2.32
2	3	1	3.06	2.51
Average			2.93	2.42

Animal No.	Sex	Body Weight (g)					Mortality
Animal No.	Sex	Initial	Day 1	Day 3	Day 7	Day 14	Day	Weight (g)
3301	M	253	215	215	237	279	E	-
3302	M	267	229	201	216	236	E	-
3303	M	242	211	201	223	238	E	-
3304	M	248	211	192	-	-	7	178
3305	M	265	230	240	269	298	E	-
3306	F	193	169	155	168	197	E	-
3307	F	199	172	158	-	-	5	139
3308	F	179	157	-	-	-	2	149
3309	F	196	171	171	-	-	6	169
3310	F	170	163	167	173	183	E	-

Registration Dossier

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Diss Factsheets

Reaction mass of Ammonium bisethanedioato bisaquo niobate(V) (anhydrous form) and Ammonium hydrogen ethanedioate ethanedioic acid (anhydrous form)

Endpoint summary

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint conclusion

Acute toxicity: via inhalation route

Link to relevant study records

Reference

TABLE 1: GRAVIMETRIC CHAMBER CONCENTRATIONS

TABLE 2: SUMMARY OF PARTICLE SIZE DISTRIBUTION

TABLE 3: INDIVIDUAL BODY WEIGHTS AND MORTALITY (5.10 mg/L)

TABLE 4: INDIVIDUAL CAGE-SIDE OBSERVATIONS (5.10 mg/L)

TABLE 5: INDIVIDUAL NECROPSY OBSERVATIONS (5.10 mg/L)

Endpoint conclusion

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint conclusion

Additional information

Justification for classification or non-classification