Sodium 4-hydroxyphenylglycolate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

number of dose levels, no necropsy

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxyphenylglycolic acid

EC Number:

214-839-7

EC Name:

4-hydroxyphenylglycolic acid

Cas Number:

1198-84-1

Molecular formula:

C8H8O4

IUPAC Name:

hydroxy(4-hydroxyphenyl)acetic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, 69210 Saint Germain sur l'Arbresle
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 95 to 140 g
- Fasting period before study: yes
- Housing: polycarbonate cages, 0.42x0.27x0.15 m
- Diet: reference B 04, U.A.R., 91360 Villemoisson-sur-Orge
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Humidity (%): 55% ± 5%
- Air changes: 11 per hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 02.03.1979 To May 1979

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1% in water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 240-320 mg/mL
- Amount of vehicle: 25 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: 78215
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 25 mL/kg

Doses:

6000, 7000, 7500, 8000 mg/kg bw
(preliminary study: 5000 and 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality (D0, D1, D4, D7 and D14), clinical signs (1h post-treatment and the daily), body weight (D0, D4, D7 and D14)
- Necropsy of survivors performed: no

Statistics:

The LD50 is determined with the Litchfield & Wilcoxon method.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

7 600 mg/kg bw

Based on:

test mat.

95% CL:

> 7 300 - < 7 900

Mortality:

No mortality is observed at 6000 mg/kg bw.
At 7000, 7500 and 8000 mg/kg bw, mortality is increased with the dose level. See table.

Clinical signs:

other: 6000 mg/kg bw: no effect 7000 mg/kg bw: piloerection (D1 only) 7500 mg/kg bw: coma, slow respiration, half-closed eyes (1 rat on D0) 8000 mg/kg bw: piloerection, prostration (D0). 8 deaths on D1. Lacrimation, half-closed eyes, prostration, piloerection, a

Gross pathology:

not examined

Any other information on results incl. tables

Mortality:

dosis	cumulated mortality
(mg/kg)	1h	D0	D1	D4	D7	D14	total %
6000		0	0	0	0	0	0
7000		0	1	1	1	1	10
7500		1	1	2	3	3	30
8000		0	8	10	10	10	100

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study in rats the oral LD50 is 7600 mg/kg bw (female, gavage)

Executive summary:

In an acute oral toxicity study, groups of fasted Wistar rats (10 females/dose level) were given a single oral dose of 4-Hydroxyphenylglycolic acid in CMC 1% at doses of 6000, 7000, 7500 and 8000 mg/kg bw and observed for 14 days.

Oral LD50 Female = 7600 mg/kg bw (95% C.I.: 7300 -7900)

Based on this LD50, 4-Hydroxyphenylglycolic acid is not classified according to the CLP/GHS criteria.