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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: in accordance with the guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
Single oral application by gavage of 1000, 2500, 2750, 3000, 3500, 4000 or 5000/kg bw (male rats) and 500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw (female rats) in 0.5 ml lutrol/100g bw to 15 male and 15 female Wistar rats per dose. Observation period: 14 d, gross pathological examination, calculation of LD50 by Probit analysis.
Study design similar to OECD TG 401.
GLP compliance:
no
Test type:
standard acute method

Test material

1
Chemical structure
Reference substance name:
2-chlorotoluene
EC Number:
202-424-3
EC Name:
2-chlorotoluene
Cas Number:
95-49-8
Molecular formula:
C7H7Cl
IUPAC Name:
1-chloro-2-methylbenzene
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
Male rats: 1000, 2500, 2750, 3000, 3500, 4000 or 5000 mg/kg bw
Female rats: 500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw
No. of animals per sex per dose:
15
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 227 mg/kg bw
Mortality:
See table below

Any other information on results incl. tables

Mortality:





















































mg/kg bwMalemg/kg bwFemale
10000/155000/15
25000/1510000/15
27503/1525000/15
30005/1530001/15
350010/15- 
400014/1540009/15
500015/15500014/15

 


Mortality (male rats):
up to 2500 mg/kg bw no rat died
from 2750 mg/kg bw onward dose-related increase in mortality (2750 mg/kg bw: 3/15; 5000 mg/kg bw: 15/15)
Signs of intoxication from 2500 mg/kg bw onwards:
poor condition until the 10th day post application and for at least 3 days accompanied by sedation and difficulties in breathing and at higher doses by quasi-narcotic effects.


LD50 (male rats): 3227 (3060-3430) mg/kg bw


Mortality (female rats)
up to 2500 mg/kg bw no rat died
from 3000 mg/kg bw onward dose-related increase in mortality (3000 mg/kg bw: 1/15; 5000 mg/kg bw: 14/15)
Signs of intoxication from 1000 mg/kg bw onwards:
poor condition until the 10th day post application and for at least 3 days accompanied by sedation and difficulties in breathing and at higher doses by quasi-narcotic effects.
LD50 (female rats): 3860 (3542-4198) mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Single oral application by gavage to male and female Wistar rats resulted in an LD50 (male rats) of 3227 mg/kg bw and an LD50 (female rats) of 3860 mg/kg bw.

Executive summary:

In a reliable study the substance was applied once by gavage at doses of 1000, 2500, 2750, 3000, 3500, 4000 or 5000/kg bw (male rats) and 500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw (female rats) in 0.5 ml lutrol/100g bw to 15 Wistar rats per sex and dose. The observation period was 14 days. Gross pathological examination was performed and the  LD50 was calculated by Probit analysis.


The LD50 (male rats) was 3227 mg/kg bw, the LD50 (female rats) was 3860 mg/kg bw). At at necropsy 14 days post application a reduced size of abdominal organs, especially liver size was found. Mucus membrane of the stomach with focus of inflammation, stomach content appeared to be bloody.