Reaction mass of 3,4,5-trichlorophthalic acid, strontium salt and 3,4,6-trichlorophthalic acid, strontium salt and 3,4-dichlorophthalic acid, strontium salt and 3,5-dichlorophthalic acid, strontium salt and 3,6-dichlorophthalic acid, strontium salt and 3-chlorophthalic acid, strontium salt and 4,5-dichlorophthalic acid, strontium salt and 4-chlorophthalic acid, strontium salt

Endpoint summary

Description of key information

In an acute oral toxicity study (fixed dose procedure, OECD 420), five female WISTAR Crl: WI(Han) rats, were treated with a single oral dose of 2000 mg/kg body weight of strontium dichlorophthalate in corn oil and were observed for 14 days. Based on the results and in accordance with OECD guideline 420 the LD50 cut-off value was determined to be 2000 mg/kg bw , the test item is classified as GHS category 5. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

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:

2019-09-12 to 2019-12-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Dynamit Nobel GmbH Explosivstoff- und Systemtechnik; Batch: WE: 50352354
- Expiration date of the lot/batch: 28 November 2019
- Purity test date: 2 September 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: In order to get the test item in a solution or suspension, which is applicable to the animals, corn oil was evaluated as vehicle and was considered to be adequate. The test item was weighed out into a tared plastic vial on a precision balance. The dose formulations were made shortly before each dosing occasion. The test substance was finely ground, and a suspension was made prior to the administration and stirred throughout the dose administration to guarantee stability and homogeneity.
For animal no. 1, 1.01547 g of the test item was dissolved in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For animal no. 2, 1.01885 g of the test item was dissolved in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For animal nos. 3, 4 and 5, 2.00100 g of the test item was dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 – 11 weeks
- Weight at study initiation:
animal no. 1: 175 g;
animal no. 2: 200 g;
animal no. 3: 203 g;
animal no. 4: 213 g;
animal no. 5: 202 g
- Fasting period before study: 17 to 18 hours
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days

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

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE: Corn oil
- Amount of vehicle (if gavage): 0.2 g/mL
- Justification for choice of vehicle: This vehicle was chosen due to its non-toxic characteristics.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Sighting study: 1 female
Main study: 4 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
The animals were observed for clinical signs once daily until the end of the observation period, with one exception. The clinical examination of animal nos. 3, 4 and 5 was not performed on observation day 9 (the clinical examination on that day was inadvertently omitted).
- Necropsy of survivors performed: yes

Statistics:

Statistical analysis was not performed.

Preliminary study:

The most relevant clinical signs observed during the sighting study were a slight reduction of the spontaneous activity, hunched posture, piloerection (slight) and half eyelid-closure. The animal recovered 48 hours post-dose.

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration.

Mortality:

All animals survived until the end of the study.

Clinical signs:

other: The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity (slight), hunched posture, piloerection (slight) and half eyelid-closure. All animals recovered 24 hours post-dose.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

In an acute oral toxicity study in rats conducted according to OECD 420, five female rats, were treated with a dose of 2000 mg/kg body weight of strontium dichlorophthalate. All animals survived until the end of the study showing signs of toxicity. Based on the results and in accordance with OECD guideline 420 the LD50 cut-off value was determined to be 2000 mg/kg bw , the test item is classified as GHS category 5. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

Executive summary:

In an acute oral toxicity study (fixed dose procedure, OECD 420), five female WISTAR Crl: WI(Han) rats, were treated with a single dose of 2000 mg/kg body weight of the test item in corn oil by oral gavage administration and were observed for 14 days. All animals survived until the end of the study showing slight signs of toxicity such as reduced spontaneous activity, hunched posture, piloerection and half eyelid-closure. All animals recovered 24 hours post-dose. At necropsy, no treatment-related macroscopic findings were observed in any animal. Based on the results and in accordance with OECD guideline 420 the LD50 cut-off value was determined to be 2000 mg/kg bw , the test item is classified as GHS category 5. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity study (fixed dose procedure, OECD 420), five female WISTAR Crl: WI(Han) rats, were treated with a single oral dose of 2000 mg/kg body weight of strontium dichlorophthalate in corn oil and were observed for 14 days. All animals survived until the end of the study showing slight signs of toxicity such as reduced spontaneous activity, hunched posture, piloerection and half eyelid-closure. All animals recovered 24 hours post-dose. At necropsy, no treatment-related macroscopic findings were observed in any animal. Based on the results and in accordance with OECD guideline 420 the LD50 cut-off value was determined to be 2000 mg/kg bw , the test item is classified as GHS category 5. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.

Justification for classification or non-classification

Based on the available data, the LD50 cut-off value was determined to be 2000 mg/kg bw , strontium dichlorophthalate is classified as GHS category 5. Therefore, classification for acute oral toxicity according to the CLP regulation 1272/2008 is not warranted.