(benzylamine)trifluoroboron

Endpoint summary

Description of key information

Acute oral toxicity, GLP, OECD 401, male and female rats, substance solved in tap water, LD50 for both sexes 641 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:

November 1994 - February 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Umweltministerium Baden-Württemberg, Stuttgart, Germany

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Batch 3078183

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Süddeutsche Versuchstierfarm, Oberer Bann 37, D-78532 Tuttlingen
- Veterinary preliminary examination: without morbid signs, females are nulliparous and non-pregnant
- Weight at study initiation: 181 - 241 g
- Fasting period before study: overnight
- Housing: individually in Macrolon cages (area 800 cm2, height 17 cm
- Diet (e.g. ad libitum): ALMA 0801 H 1003 (ALMA-Futter Friedrich Botzenhardt KG, D-87437 Kempten/Allgäu), twice 8 g daily
- Water (e.g. ad libitum): free access by daily changing of the watering bottles
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 : 12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Sample was diluted in the statet doses per kg body weight with 1.5 ml tap water and was administered to the rats by means of a stomach tube. Food was withheld for further 4 hours.

Doses:

Group I: 125 mg / kg bw
Group II: 500 mg / kg bw
Group III: 2000 mg / kg bw

No. of animals per sex per dose:

each group consists of 5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily weighing, observations on first day 5 min, 30 min, 4 h after administration, then daily
- Necropsy of survivors performed: yes
- Other examinations performed: behavior pattern and toxicological symptoms (changes of hair, skin, nose and mouth with muscous membrane, eye, anal region, excrements, urine (macroscopic), respiration, circulation, nervous system and behavoir

Statistics:

The LD50 calculation was performed according to "Moving Averages" (Shayne C. G.; Weil C. S.; in Hayes, Principles and Methods of Toxicology, Raven Press, New York 1984, Student Edition, 273).

Sex:

male

Dose descriptor:

other: mortality 20%

Effect level:

125

Based on:

test mat.

Remarks on result:

other: 1 out of 5 died

Sex:

female

Dose descriptor:

LD0

Effect level:

125

Based on:

test mat.

Remarks on result:

other: 0 out of 5 died

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

500

Based on:

test mat.

Remarks on result:

other: 1 out of 5 died

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

500

Based on:

test mat.

Remarks on result:

other: 2 out of 5 died

Sex:

male

Dose descriptor:

LD100

Effect level:

2 000

Based on:

test mat.

Remarks on result:

other: 5 out of 5 died

Sex:

female

Dose descriptor:

LD100

Effect level:

2 000

Based on:

test mat.

Remarks on result:

other: 5 out of 5 died

Mortality:

In group I one male animal was found dead in the morning of the eleventh day. In group II a male and a female animal died in the first hour after administration. One female animal was found dead in the morning of the second day. In group III two male and two female animal died during the first two hours after administration. All other animals were found dead in the morning of the first day.

Clinical signs:

Acute toxicological symptoms attributed to the exposure to the test substance could be observed in four rats of group I (125 mg / kg bw) and in all rats of group II (500 mg / kg bw) and of group III (2000 mg / kg bw).

Body weight:

see table below.

Gross pathology:

No macroscopical findings in group I and II. Macroscopical organ changes (dark-red coloured gut) in two male animals of group III.

Other findings:

no other findings reported

Body weight (statements in g):

	female					male
animal no.	620	621	622	623	624	625	626	627	628	629
group I, day 0	204	198	205	207	215	212	241	212	219	204
1	199	212	222	224	226	227	260	230	223	224
2	-	-	-	-	-	-	-	-	-	-
3	217	218	238	227	241	231	271	243	233	220
4	224	216	229	230	237	232	272	243	229	214
5	223	218	224	235	234	230	268	244	224	214
6	226	228	226	232	238	228	275	243	216	225
7	221	227	233	234	242	230	276	247	195	220
8	223	231	235	230	246	235	283	251	177	222
9	-	-	-	-	-	-	-	-	-	-
10	242	250	233	247	255	265	305	272	151	247
11	240	247	236	244	253	260	299	267	+	244
12	237	241	236	244	252	258	296	261		240
13	238	247	235	243	253	256	295	267		242
14	238	248	248	247	255	259	306	274		252
	female					male
animal no.	610	611	612	613	614	615	616	617	618	619
group II, day 0	206	194	193	190+	208	197+	207	198	211	200
1	212	185	200		210		219	215	222	219
2	215	+	202		223		221	214	236	224
3	212		202		219		224	225	235	218
4	-		-		-		-	-	-	-
5	215		205		221		230	223	239	222
6	211		209		220		227	225	238	221
7	212		207		222		226	220	232	219
8	216		209		225		229	225	236	225
9	216		204		223		233	223	240	230
10	223		209		225		234	230	241	228
11	-		-		-		-	-	-	-
12	235		227		244		265	261	274	262
13	227		227		241		267	257	271	263
14	236		231		243		261	251	267	259
	female					male
animal no.	560	561	562	563	564	565	566	567	568	569
group III, day 0	194	188+	181+	188	179	197	221+	208	215+	230
1	+			+	+	+		+		+

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Harmful if swallowed Criteria used for interpretation of results: other: EU-GHS

Conclusions:

The study was performed according to the OECD TG401 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material did induce mortality in the dose groups of 2000 mg/kg bw (100 % mortality), 500 mg/kg bw (30 % mortality) and 125 mg/kg bw (10 % mortality) and treatment-related clinical signs in all dose groups. According to OECD guideline 401 the LD50 of the test item is 641 mg/kg bw. The test material was considered to be harmful if swallowed after oral application under the conditions of the test and has to be classified as GHS Category 4.

Executive summary:

The test substance was administered orally in a single dose to three groups of Sprague-Dawley rats:

Group I (5 male and 5 female rats), 125 mg / kg bw applied

Group II (5 male and 5 female rats), 500 mg / kg bw applied

Group III (5 male and 5 female rats), 2000 mg / kg bw applied

Acute toxicological symptoms attributed to the exposure to Lekutherm Beschleuniger KU 6519 could be observed in four rats of group I and in all rats of group II and of group III. The post-mortem-findings of all 30 rats of the test show macroscopical organ changes of the gut of two rats out of 10 of the dosage group of 2000 mg / kg bw. The other rats show no macroscopical organ changes in the pathological examinatioon. The LD50 value of Lekutherm Beschleuniger KU 6519 was estimated to be 707 mk/kg bw for male rats and 574 mg / kg bw for female rats addording to the calculation by moving averages interpolation.

The LD50 value for both sexes is 641 mg / kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

641 mg/kg bw

Additional information

The study was performed according to the OECD TG401 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled. The test material did induce mortality in the dose groups of 2000 mg/kg bw (100 % mortality), 500 mg/kg bw (30 % mortality) and 250 mg/kg bw (10 % mortality) and treatment-related clinical signs in all dose groups. According to OECD guideline 401 the LD50 of the test item is 641 mg/kg bw. The test material was considered to be harmful if swallowed after oral application under the conditions of the test and has to be classified as GHS Category 4.

Justification for selection of acute toxicity – oral endpoint
well documented GLP-guideline Study, which used a vehicle without concern.

Justification for classification or non-classification

According to OECD guideline 401 the LD50 of the test item is 641 mg/kg bw. The test material was considered to be harmful if swallowed after oral application under the conditions of the test and has to be classified as GHS Category 4.