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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28.11.2002 - 06.01.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study procedures described in this report meet or exceed the requirements of the following guidelines: OECD Guidelines for the Testing of Chemicals, Number 423 "Acute Oral Toxicity - Acute Toxic Class Method", adopted 17 December 2001 . Directive 96/54/EEC, 8.1 tris "Acute Oral Toxicity-Acute Toxic Class Method", September 30, 1996.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide
EC Number:
617-191-7
Cas Number:
81060-07-3
Molecular formula:
C14H20Br2N2 x HBr
IUPAC Name:
2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): BROMHEXINE HYDROBROMIDE
- Physical state: white powder
- Lot/batch No.: 02070864
- Expiration date of the lot/batch: Retest date 30-JUNE-2003
- Storage condition of test material: at room temperature, in the dark

Test animals

Species:
rat
Strain:
other: HanBrl: Wist (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Anima! Breeding Division, CH-4414 Füllinsdorf I Switzerland
- Age at study initiation: Males: 9 weeks, Females: 12 weeks
- Weight at study initiation: males: 247 - 267g, femals: 190 - 192 g
- Fasting period before study: approximately 18 hours
- Housing: Makroion type-4 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Under Iabaratory conditions, after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light/ 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE

- Amount of vehicle (if gavage): 10 ml/kg body weight
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3 femals / 3 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during acclimatization and twice daily during days 1-15.
Weighing: On test days 1 (prior to administration), 8 and 15
Clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during
days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was used

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study
Clinical signs:
Slightly ruffled fur was noted in all female animals from test day 4 to 6 and in all male
animals from test day 6 to 7.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median Iethal dose of BROMHEXINE HYDROBROMIDE after singleoral administration
to rats of both sexes, observed over a period of 14 days is:
LDso (rat): greater than 2000 mg/kg body weight