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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
24 April to 9 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (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:
2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate
Cas Number:
1364731-90-7
Molecular formula:
C14H14O4S
IUPAC Name:
2,6-dimethylphenyl 4-hydroxybenzene-1-sulfonate

Test animals

Species:
rat
Strain:
other: CRL: WI
Sex:
female
Details on test animals or test system and environmental conditions:
Species and strain: CRL:(WI) rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level at arrival: SPF
Hygienic level during
the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 9 weeks old
Body weight at treatment: 201 – 209 g
Acclimation period: At least 5 days
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/5
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
A copy of the Certificate of Analysis is retained in the archive at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Ventilation: 15 – 20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: PEG 400
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The substance did not cause mortality at a dose level of 2000 mg/kg bw.
Clinical signs:
other: Treatment did not cause any clinical signs during the 14 days observation period.
Gross pathology:
There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 is >2000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity was assessed by gavage dosing to female CDR:(WI) rats at a dose level of 2000 mg/kg bodyweight according to the OECD 423 test guideline and in compliance with GLP. No mortality, effects to bodyweight or clinical signs were observed and the LD50 is >2000 mg/kg bodyweight