Dibenzoyl-L-tartaric acid monohydrate

Endpoint summary

Description of key information

Key study. Method similar to OECD 401 (non-GLP study). The oral LD50 of the test item in rats is > 5000 mg/kg bw.

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:

10/02/1986 - 14/03/1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

limit test at 5000 mg/kg bw

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, 0-7950 Biberach, FRG
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: animals of comparable weight (mean ± 20 %). In the main test, average weight was 180g (M) and 179g (F).
- Fasting period before study: 16h
- Housing: animals were housed in fully air-conditioned rooms. 5 animals per cage were housed in stainless steel wire mesh cages, type DK-III (Becker&Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet, Fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum.
- Water: tap water ad libitum.
- Acclimation period: at least 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6.00 - 18.00 h / 18.00 - 6.00 h)

IN-LIFE DATES: From: 12.02.86 To: 26.02.86

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% aqueous CMC

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %(w/v)
- Amount of vehicle (if gavage): 20 ml/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.

Doses:

- Preliminary study: 2000 mg/kg bw.
- Main study: 5000 mg/kg bw.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptoms was performed 15, 30 min, 1, 2, 4, 5 h, and D1, D2, D5, D6, D7, D8, D9, D12, D13, D14 after administration; check for moribund or dead animals twice daily or once on holidays; animal weights were recorded on D7 and D13.
- Necropsy of survivors performed: yes, on D14 (after sacrifice).
- Other examinations performed: clinical signs, body weight.

Preliminary study:

In a preliminary study conducted with 2 male and 2 female wistar rats, administered a single dose of 2000 mg/kg bw test item and observed for 7 days, no relevant signs of toxicity were observed and no mortalities occurred.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No abnormalities were observed.

Gross pathology:

No gross lesions were noted in any organs of the animals on day 14.

Table 1. Summary of results.

TI: 5000 mg/kg		1 H	1 D	2 D	7 D	14 D	Necropsy findings	LD50 > 5000 mg/kg bw (1% significance level)
Mortality	M	0/5	0/5	0/5	0/5	0/5	No abnormalities detected
	F	0/5	0/5	0/5	0/5	0/5
Avg. weight (g)	M	180	-	-	234	263
	F	179	-	-	204	214

 

Interpretation of results:

GHS criteria not met

Remarks:

EU criteria

Conclusions:

The LD50 of the test item in rats is > 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test item in rats was studied by a method similar to OECD TG 401 (non-GLP study). Based on the results of a preliminary test, a limit test was performed by administering a single dose of 5 g/kg bw test item to 10 (5M/5F) Wistar rats, and observing the effects for 14 days (survival, clinical signs, body weights, necropsy). All animals were thoroughly observed twice daily on workdays and once on weekends. No treatment-related effects were observed in any animal, no mortality occurred and no abnormalities were found upon necropsy. Therefore, the test item is not toxic to rats, with an LD50 > 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute oral toxicity of the test item in rats was studied by a method similar to OECD TG 401 (non-GLP study). Based on the results of a preliminary test, a limit test was performed by administering a single dose of 5 g/kg bw test item to 10 (5M/5F) Wistar rats, and observing the effects for 14 days (survival, clinical signs, body weights, necropsy). All animals were thoroughly observed twice daily on workdays and once on weekends. No treatment-related effects were observed in any animal, no mortality occurred and no abnormalities were found upon necropsy. Therefore, the test item is not toxic to rats, with an LD50 > 5000 mg/kg bw.

Justification for classification or non-classification

Based on available results (LD50(oral, rat) > 5000 mg/kg bw), the test item is not classified for acute toxicity, according to CLP Regulation (EC) No. 1272/2008.