2H-Indol-2-one, 1,3-dihydro-1-phenyl-

Endpoint summary

Description of key information

Acute dermal toxicity: 
Key study: OECD guideline 402 and EU method B.3. GLP study.
The dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Start : 30 January 2002 End : 13 February 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: There are no deviations from the recommended guidelines.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Wistar strain Crl:(WI) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sillzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: males: 341-378 g; females: 205-253 g
- Housing: lndividually housed in labelled polycarbonate cages (type III, height 15 cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet (e.g. ad libitum): Standard pelleted laboratory animal diet (from Altromin (code VRF 1) , Lage, Germany), ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: At least 5 days before start of treatment under laboratory conditions.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3ºC
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.


IN-LIFE DATES: Start : 30 January 2002; End : 13 February 2002

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25 cm2 for males and 18 cm2 for females.
- % coverage: 10% of the total body surface.
- Type of wrap if used: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D),
successively covered with aluminium foil and Coban flexible bandagee. A piece of Micropore tape was additionally used for fixation of the bandages in females only.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed using water.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 ml/kg)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales. No observation for clinical signs was performed on day 2 of the study. Since sufficient information on clinical signs was availabie, this protocol deviation was considered not to have affected the study integrity. Body weights were recorded on Days 1 (pre-administration), 8 and 15.

- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was required.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: One female showed chromodacryorrhoea between days 6 and 13. No further signs of systemic toxicity were noted among the animals. Erythema and scales were seen on the back of one female between days 4 and 9.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Table 7.2.3:      Summary of Acute Dermal Toxicity

Males			Females
Dose	Mortality	Time of death	Dose	Mortality	Time of death
2000 mg/kg bw	0/5	--	2000 mg/kg bw	0/5	--

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 value of Phenyloxindole in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

Phenyloxindole was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. One female showed chromodacryorrhoea between days 6 and 13. No further signs of systemic toxicity were noted among the animals. Erythema and scales were seen on the back of one female between days 4 and 9. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal in treated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination. The dermal LD50 value of Phenyloxindole in Wistar rats was established to exceed 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.

Additional information

Acute dermal toxicity:

Key study: OECD guideline 402 and EU method B.3. GLP study.

The dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity.