Benzoic acid, 2-[[3-(4-hydroxyphenyl)-1-oxopropyl]amino]-

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP compliant)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-04-20 to 2004-05-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001-12-17

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

, 2004

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - stock Shoe:WIST
- Source: DIMED Schönwalde GmbH, Schönwald, Germany
- Weight at study initiation: test group: 133 g - 144 g; vehicle control group 131 g - 140 g
- Fasting period before study: rats fasted overnight prior to dosing. After dosing diet was withheld for 4 more hours.
- Housing: rats were kept in transparent polycarbonate cages (Macrolone type III, floor area 810 cm2) with two or three in each cage. Bedding was pinewood sawdust "Lignocel-Fasern" (Altromin, Lage, Lippe, Germany).
- Diet (ad libitum): a pelleted complete rodent diet "Altromin 1314" (Altromin GmbH, Lage, Lippe, Germany)
- Water (ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21°C ± 3°C
- Relative humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
Propylenglycol was used as the vehicle and its toxicological harmlessness was shown with an additional control group.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION: for the preparation of the test item a dispersion tool (Ultra-Turrax T25) was used.

The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg bw. An additional control group consisting of three female animals was given the vehicle only.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Test group: 6 female rats
Vehicle control group: 3 female rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each rat was observed 30 minutes, 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes, all rats were killed by inhalation of CO2 an day 14 and subjected to a gross necropsy examination.

Statistics:

none

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Neither animals of the control group nor of the two test groups died on account of the treatment nor did they show severe signs of toxicosis.

Clinical signs:

other: Vehicle control group : The 3 female rats showed a hunched posture and piloerection 30 minutes after the application of the vehicle. After 2 and 4 hours piloerection was still observed, whereas the three rats showed normal behaviour after 6 hours. From d

Gross pathology:

The gross necropsy revealed no pathological abnormalities.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 (female rats) > 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

One reliable animal study according to OECD 423 (key_acute toxicity, oral_2008_RL 1) is considered to be reliable without restrictions. The LD50 was determined to be greater than 2000 mg/kg bw. The test item is not acutely toxic via the oral route.

Justification for selection of acute toxicity – oral endpoint
GLP guideline study with the test item

Justification for classification or non-classification

Acute oral toxicity

The available guideline-conform study conducted under GLP indicate that test item is not acutely toxic via the oral route. Thus, according to Directive EEC 67/548 and to Regulation (EC) No. 1272/2008, no classification or labelling is required.

Specific target organ toxicant (STOT) - single exposure: oral

The classification criteria according to Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value, oral for a Category 2 classification (2000 mg/kg bw ≥C > 300 mg/kg bw). No classification required.