Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study performed according to OECD 423 Guideline under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-trichlorobenzene
EC Number:
203-608-6
EC Name:
1,3,5-trichlorobenzene
Cas Number:
108-70-3
Molecular formula:
C6H3Cl3
IUPAC Name:
1,3,5-trichlorobenzene
Test material form:
solid
Details on test material:
• Sponsor’s identification: TCB (1,3,5-trichlorobenzène)
• Batch No.: 171882
• Category: Chemical Substance
• Date received: 17 September 2021
• EINECS No.: 203-608-6
• Container: plastic flask (n=1)
• CAS No : 108-70-3
• Quantity: 101.00 g (container + content + label)
• Form: solid
• Homogeneity: yes • Colour: white
• Production date: not provided
• Expiry date: February 2024
• Storage: room temperature
• Purity: 99,85 %
• Stability: stable under storage conditions
• Composition : 99.85 % 1,3,5-trichlorobenzène

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Remarks:
olive oil
Doses:
4 groups of 3 rats exposed to 300 mg/kg and 2000 mg/kg
No. of animals per sex per dose:
6 rats exposed to 300 mg/kg and 6 rats exposed to 2000 mg/kg
Details on study design:
The standard study plan related to this study was approved by the registered Ethics Committee No. 76.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item TCB (1,3,5-trichlorobenzène) is higher than 2000 mg/kg body weight.
In accordance with the O.E.C.D. Test Guideline No. 423, the LD50 cut-off of the test item may be
considered as 5000 mg/kg body weight by oral route in the rat.
The test item TCB (1,3,5-trichlorobenzène) does not have to be classified in accordance with the
Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.
Executive summary:

Group treated at 300 mg/kg body weight:
One mortality (1/6) was noted in animals treated at 300 mg/kg body weight. This mortality was noted
5 min after the treatment with the test item. It is suspected a gavage injury.
Rigor mortis was noted before the necropsy.
The necropsy did not reveal treatment related changes.
In surviving animals (5/6), no clinical signs related to the administration of the test item were observed
during the study.
The body weight evolution of the animals remained normal during the study.
The macroscopic examination of the animals at the end of the study did not reveal treatment related
changes.
Group treated at 2000 mg/kg body weight:
No mortality was noted in animals treated at 2000 mg/kg body weight.
A decrease in spontaneous activity (2/6) and eyes partly closed (3/6) were noted at 1-hour and 3-hour
post-dose. An increase of salivation (2/6) was also noted at 30 minutes and 1-hour post-dose.
The body weight evolution of the animals remained normal during the study.
The macroscopic examination of the animals at the end of the study revealed a thin proventricular wall
(1/6) and fundic wall disintegrating when touched (3/6).