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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
80419-48-3
Test material form:
solid
Details on test material:
beige powder
Specific details on test material used for the study:
Analogy
CAS 80419-48-3, 2-chloro-6-methyl-3-aminophenol -hydrochloride

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Acclimatisation period: at least 5 days under housing conditions
Water: tap water ad libitum
Diet: ad libitum
Room temperature/relative humidity: approx. 20-25°C / 45 -60 %
Day/night cycle: 12 hours/12 hours
Fasting period:
Food deprivation: approx. 16 hours prior to and until 3 hours after application

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
single dose application, application volume of 20 ml/kg body weight
Doses:
group 1: 0.501 g/kg = 2.5%
group 2: 1.00 g/kg = 5.0%
group 3: 1.25 g/kg = 6.25%
group 4: 1.58 g/kg = 7.9%
group 5: 1.99 g/kg = 9.95%
No. of animals per sex per dose:
group 1, group 2, group 4, group 5 : 10 male rats
group 3: 20 male rats

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 360 mg/kg bw
Mortality:
deaths occured after 1-24 hours after application
Clinical signs:
other: above a dose of : 0.5 g/kg: apathetic, dizzily, accelerated breathing, later difficult respiration, prone position, urinary excretion (yellow-orange)

Any other information on results incl. tables

Mortality - male rats

 group number  dose g/kg  number of animals  number of dead animals  number of animals with sypmtoms

 1

 0.501

10 

 0

10

 2 1.00  10   1 10
 3 1.25 20  9 20 
 4 1.58  10  8 10 
 5 1.99 10  9 10 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the given results 2 -chlor-6-methyl-3-aminophenol-hydrochloride has to be considered as harmful.
Executive summary:

The acute oral toxicity of 2 -chlor-6-methyl-3-aminophenol-hydrochloride was tested in young TNO - Wistar rats, supplier Winkelmann, Borchen. 10 - 20 male animals with a mean body weight of 200 g were used per dose. The test compound was administered by gavage in aqua dest. as solvent and an application volume of 20 ml/kg body weight.

The LD50 for male rats was 1.36 (1.21 - 1.54) g/kg.