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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 9, 2014 - August 11, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is conducted according to the current guideline and in compliance with GLP:

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Not applicable
EC Number:
940-936-5
Molecular formula:
C4H12NCl.C4H12NOCl
IUPAC Name:
Not applicable
Details on test material:
- Name of test material (as cited in study report): Halo Salt
- Physical state: liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Al, Ca,Cr,Co,Cu,Fe,Pb,Mg,Ni,K,Na,Sn,Ti,Zn < 100 ppb
- Composition of test material, percentage of components:Tetramethylammonium Hydroxide 1.34 (wt.%), Available Chlorine 8.31 (wt.%), Stabilizer 0.12 (wt%)
- Purity test date: August 27, 2013
- Lot/batch No.: 0000054875
- Storage condition of test material: Store in well-closed, light resistant containers.

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kingston, NY
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: 179g to 212g
- Fasting period before study: overnight
- Housing: All rats were housed individually in clean, stainless steel, wire-mesh cages suspended above cage-board until euthanasia.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC, Certified Rodent LabDiet® 5002 ad libitum throughout the acclimatisation period and during the study except overnight period prior to dosing
- Water (e.g. ad libitum): Municipal water ad libitum throughout the acclimatisation period and during the study except overnight period prior to dosing
- Acclimation period: minimumoof 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71°F ± 5°F (22°C ± 3°C)
- Humidity (%): 50% ± 20%
- Air changes (per hr): 10 fresh air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
20-JUL-2014 Animals fasted
21-JUL-2014, 24-JUL-2014, 28-JUL-2014 Test article administration
11-AUG-2014 Last necropsy

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
For the 300 mg/kg group, the test substance was dosed undiluted. The dose volume of 0.29 mL/kg.

For the 50 mg/kg group, the test substance was dosed at a diluted concentration of 5 mg/mL. The dose volume of 10 mL/kg.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The recent toxicity information from 10-D dose range finding study shows that the substance caused mortality (one rat died at study day 1, 3, 4) when dosed repeatedly at 200 mg/kg bw (Baracani, R. (2014).
Doses:
300 mg/kg bw, 50 mg/kg bw
No. of animals per sex per dose:
3 females / dose (300mg/kg) and 6 (3+3) females / dose (50mg/kg)
Control animals:
no
Details on study design:
All 3 females at 300 mg/kg died. Therefore, 3 females were dosed at 50 mg/kg. No mortality was observed, and 3 additional females were dosed at 50 mg/kg. Again, no mortality was observed, and therefore, no additional rats were dosed.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at approximately 15 minutes (± 5 minutes) and 1, 2 and 4 hours post-dosing on study day 0 and twice daily, once in the morning and once in the afternoon.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 50 - < 300 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mortality
Mortality:
300 mg/kg 3/3
50 mg/kg 0/6
Clinical signs:
other: There were no clinical observations for the 50 mg/kg group females.
Gross pathology:
There were no test substance-related macroscopic findings. One female in the 300 mg/kg group that died had clear uterine contents.
Other findings:
- Organ weights: not measured
- Histopathology: not done
- Potential target organs: not found
- Other observations: not done

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information This study result is used for a classification Criteria used for interpretation of results: EU
Conclusions:
Fasted female albino rats were administered with HaloSalt once orally via gavage. The estimated LD50 of Halo Salt was greater than 50 mg/kg but less than 300 mg/kg.
Executive summary:

The objectives of this study were to determine the estimated acute oral median lethal dose and evaluate potential systemic toxicity of the test substance when administered as a single dose to albino rats.

The study is considered reliable without restrictions since the study is carried out according to OECD No. 423 guideline and in compliance with principles of Good Laboratory Paractice (GLP).

Based on the results of this study, the estimated LD50 of Halo Salt was greater than 50 mg/kg but less than 300 mg/kg when administered once orally via gavage to fasted female albino rats (Acute Tox. 3).