Ammonium iodide

Endpoint summary

Description of key information

Acute oral toxicity:

The acute oral median lethal dose (LD50) for the test chemical is considered to be >2000 mg/Kg bw/day and hence the test chemical is not likely to classify as toxic as per the criteria mentioned in CLP regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the data from various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE for the target chemical is summarized based on the data from various test chemicals

GLP compliance:

not specified

Test type:

other: 2.acute toxic class method 3. No data

Limit test:

yes

Specific details on test material used for the study:

- Name of test material: Ammonium iodide
- IUPAC name: Ammonium iodide
- Molecular formula: H4IN
- Molecular weight: 144.939 g/mole
- Smiles : [NH4+].[IH-]
- Inchl: 1S/HI.H3N/h1H;1H3
- Substance type: Inorganic
- Physical state: Solid crystalline powder (colorless to white)

Species:

rat

Strain:

other: 2.Wistar 3.not specified

Sex:

female

Details on test animals or test system and environmental conditions:

2.-Source: In-house animals,bred at Animal House, sa-FORD.
- Age at study initiation:9-11 weeks at the time of dosing.
- Weight at study initiation:Minimum: 144 g
Maximum: 167 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
-Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Fasting period before study:16-18 hours
-Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 26 /2014 and SPAR – 27 /2014.
-Husbandry :The animals were housed individually in polycarbonate cages.
-Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
-Cages and water bottle:All the cages and water bottles were changed at least twice every week.
-Diet:All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 400010.
-Water: Aqua guard filtered tap water was provided ad libitum via drinking bottles.
-Acclimatisation:Animal nos. 1-3 were acclimatized for 7 days and 4-6 for 9 days, prior to administration of the test item.


Experimental Condition:
-Temperature(°C):Minimum: 19.60 °C Maximum: 21.40 °C
-Relative humidity(%):Minimum: 47.40% Maximum: 58.60%
-Air Changes(per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

IN-LIFE DATES: From:October 15, 2014
To:November, 2014

3. Not specified

Route of administration:

other: 2.oral: gavage 3.oral: unspecified

Vehicle:

other: 2. Distilled water 3.not specified

Details on oral exposure:

2. VEHICLE
- Amount of vehicle :10 ml
- Justification for choice of vehicle:distilled water was selected as a vehicle because test item was soluble in distilled water.
- Purity:N/A

MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight.

3. Not specified

Doses:

2. 2000 mg/kg bw
3. 4340 mg/kg bw

No. of animals per sex per dose:

2.total : 6 females
3. Not specified

Control animals:

not specified

Details on study design:

2.- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation:-
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 h
ours post dosing on day 0 (day of dosing). Subsequently, all surviving animals were observed once a day
during the 14 day observation period.
Mortality:
All animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the
acclimatization and study period.
Body weight:
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Pathology:
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2. All the animals were observed for external and internal gross pathology.


3. Not specified

Statistics:

no data available

Preliminary study:

no data available

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no 50% mortality was observed

Remarks:

2

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 340 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Remarks:

3

Mortality:

2. Mortality was observed in the animals no. 2 and 5 on day 0 and on day 1 respectively post dosing
3. No mortality was observed at dose 4340 mg/kg bw

Clinical signs:

other: 2. At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours, Salivation was observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes a

Gross pathology:

2. .During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.

During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion congestion was observed in animal no. 5.

3. No data available

Other findings:

no data available

Interpretation of results:

other: not classified

Conclusions:

The acute oral media lethal dose (LD50) for the test chemical is considered to be >2000 mg/Kg bw/day and hence it is likely to classified as "Not classified" for acute oral toxicity.

Executive summary:

Data available for the various test chemicals was reviewed to determine the acute oral toxicity of the test chemical Ammonium iodide (12027-06-4). The studies are as mentioned below:

Acute Oral Toxicity Study of test chemical performed on Six female Wistar Rats as per OECD No. 423. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, food was withheld but drinking water providedad libitum.Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and one mortality was observed on day 0 post dosing so anotherthree animals of the same group were dosed with 2000 mg/kg body weight and again one mortality was observed on day 1 post dosing. Hence,further dosing was stopped.Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationwas observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and 1 hour, lethargy at 2 to 4 hours,Salivationat 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationat 4 hours and normal from day 1 till termination. Animal no. 5 was observed normal at 30 minutes and 1 hour , lethargy at 2, 3, 4 hours and on day 1,Salivationat 4 hours and found dead on day 1. Animal no. 6 was observed normal at 30 minutes to 2 hour, lethargy at 3 and 4 hours and was normal from day 1 to till termination.During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion was observed in animal no. 5.Hence, The acute oral LD50 (Cut-off value) of test chemical was considered to be 2500 mg/kg body weight, when Wistar female rats were treated with test chemical orally by gavage as per OECD No. 423.

In another study, acute oral toxicity study was performed using rats. No mortality was observed at dose level of 4340 mg/kg bw. Hence, the acute oral median lethal dose (LD50) value was considered to be 4340 mg/kg bw, when rats were treated with test chemical orally.

Based on the details available and applying the weight of evidence approach, the test chemical is not likely to classify as toxic as per the criteria mentioned in CLP regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 340 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from authoritative database

Additional information

Acute oral toxicity:

Data available for the various test chemicals was reviewed to determine the acute oral toxicity of the test chemical Ammonium iodide (12027-06-4). The studies are as mentioned below:

Acute Oral Toxicity Study of test chemical performed on Six female Wistar Rats as per OECD No. 423. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, food was withheld but drinking water providedad libitum.Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and one mortality was observed on day 0 post dosing so anotherthree animals of the same group were dosed with 2000 mg/kg body weight and again one mortality was observed on day 1 post dosing. Hence,further dosing was stopped.Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. Mean Body weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationwas observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and 1 hour, lethargy at 2 to 4 hours,Salivationat 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationat 4 hours and normal from day 1 till termination. Animal no. 5 was observed normal at 30 minutes and 1 hour , lethargy at 2, 3, 4 hours and on day 1,Salivationat 4 hours and found dead on day 1. Animal no. 6 was observed normal at 30 minutes to 2 hour, lethargy at 3 and 4 hours and was normal from day 1 to till termination.During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion was observed in animal no. 5.Hence, The acute oral LD50 (Cut-off value) of test chemical was considered to be 2500 mg/kg body weight, when Wistar female rats were treated with test chemical orally by gavage as per OECD No. 423.

In another study, acute oral toxicity study was performed using rats. No mortality was observed at dose level of 4340 mg/kg bw. Hence, the acute oral median lethal dose (LD50) value was considered to be 4340 mg/kg bw, when rats were treated with test chemical orally.

Based on the details available and applying the weight of evidence approach, the acute oral median lethal dose (LD50) for the test chemical is considered to be >2000 mg/Kg bw/day and hence the test chemical is not likely to classify as toxic as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the experimental studies on Ammonium iodide (12027-06-4) and it’s closely related test chemicals, it can be concluded that acute oral median lethal dose (LD50) value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ammonium iodide (12027-06-4) cannot be classified for acute oral toxicity.