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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
Study period:
1986-04-30 to 1986-07-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(4-isopropoxyphenylsulfonyl)phenol
EC Number:
405-520-5
EC Name:
4-(4-isopropoxyphenylsulfonyl)phenol
Cas Number:
95235-30-6
Molecular formula:
C15H16SO4
IUPAC Name:
4-[4-(propan-2-yloxy)benzenesulfonyl]phenol
Details on test material:
- Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: white powder;
- Analytical purity: > 99.5 %;
- Purity test date: not stated;
- Lot/batch No.: Not stated;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd.; Huntingdon; Cambridgeshire; England;
- Age at study initiation: four to six weeks;
- Weight at study initiation: 90 to 134 g;
- Fasting period before study: overnight prior to dosing;
- Housing: metal cages with wire-mesh plates;
- Diet: Labsure LAD 1 standard laboratory rodent diet ad libitum;
- Water: municipial tap water ad libitum;
- Acclimation period: 6 days;

ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 23 °C;
- Humidity: mean 57 % R.H. daily;
- Air changes: 15 air changes per hour;
- Photoperiod: 12 hours dark/12 hours light per day;


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
D-8 was prepared at 50 % w/v in 1 % aqueous methylcellulose and administerd at a volume of 10.0 mL/kg.
The appropriate dose volume of the test substance was administered to each rat using a syringe and a plastic catheter.
Doses:
5.0 g/kg
No. of animals per sex per dose:
five males/five females
Control animals:
no
Details on study design:
Preliminary study:
A trial test was carried out by dosing two male and two female rats at 5.0 g/kg bw.
Main study:
A group of ten rats (five males and five females) was treated at 5.0 g/kg bw.

Results and discussion

Preliminary study:
No mortalities were observed during the preliminary study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed neither during the preliminary study nor the main study.
Clinical signs:
other: Pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, pallor of extremities, increased salivation and diarrhoea were observed in all rats shortly after dosing. There were no other clinical signs and recovery, as judg
Gross pathology:
Terminal autopsy findings wrere normal.
Other findings:
No other findings

Any other information on results incl. tables

The acute lethal oral dose to rats of D-8 was found to be greater than 5.0 g/kg bw.

No mortalities were found during the observation period. No significant signs of toxic effects could be detected during necropsy.

Table: Results of toxicity testing of D-8

Study

Dose (g/kg)

Mortality ratio (no. of deaths/no. dosed)

 

 

males

females

combined

Preliminary

5.0

0/2

0/2

0/4

Main

5.0

0/5

0/5

0/10

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
D-8 was tested for acute oral toxicity in rats according to EU Test Guideline B.1. The acute lethal oral dose to rats of D-8 was found to be greater than 5000 mg/kg bw.
Executive summary:

D-8 was tested for acute oral toxicity in rats. The substance was administered by gavage to male and female rats in a single dose of 5.0 g/kg bw. No mortalities occured during the observation period. No clinical signs of toxicity could be observed during necropsy after termination of the the study. It was concluded that the acute lethal oral dose for D-8 in rats was greater 5000 mg/kg bw.