Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-03-01 to 1995-03-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

31 July 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

EC Number:

250-418-4

EC Name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

Cas Number:

30989-05-0

Molecular formula:

C21H45BO12

IUPAC Name:

tris{2-[2-(2-methoxyethoxy)ethoxy]ethyl} borate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Partie 24, 05-Jan-1995; Product number / code: LP 1941
- Substance type: Borated Glycol Ether
- Expiration date of the lot/batch: stable until 05-Jul-1995
- Purity test date: Not provided
- Analytical purity: 97% (calculated after titration of boric acid)

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hoe: WISKf (SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 181-187 g (M); 160-169 g (F)
- Fasting period before study: from about 16 hours before to 3-4 hours after treatment
- Housing: macrolon cages (type 4)
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1995-03-01 To 1995-03-15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: not applicable (undiluted)
VOLUME APPLIED: 1.85 mL/kg (density = 1.08 kg/l at 20°C)
CLASS METHOD: limit dose

Doses:

2000 mg/kg body weight

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: clinical observations twice every day (in the morning and in the afternoon), on weekends and holidays only once; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

Mean values & standard deviation were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

After application of 2000 mg/kg body weight no deaths in male and female animals occurred during the 14 day observation period.

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

The animals were killed at the end of the observation period showed no macroscopically visible changes.

Any other information on results incl. tables

Table 2. Body weight and body weight gain (gram)

Male No.	Body weight			Body weight gain
	Day 1	Day 8	Day 15	Day 0	Day 8	Day 15
1	187	251	280	0	64	93
2	182	245	285	0	63	103
3	185	244	280	0	59	95
4	181	239	275	0	58	94
5	182	246	285	0	64	103
Mean	183.4	245.0	281.0	0	61.6	96.6
S.D.	2.5	4.3	4.2		2.9	5.0

 

Female No.	Body weight			Body weight gain
	Day 1	Day 8	Day 15	Day 0	Day 8	Day 15
1	160	190	204	0	30	44
2	164	190	198	0	26	34
3	169	191	217	0	22	48
4	165	199	213	0	34	48
5	163	186	204	0	23	41
Mean	164.2	191.2	207.2	0	27.0	43.0
S.D.	3.3	4.8	7.7		5.0	5.8

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg body weight B-TEGME.

Executive summary:

In an oral acute toxicity study according to OECD 401, 5 male and 5 female animals were gavaged with the limit dose of 2000 mg/kg bw/d of the test substance.

After application neither deaths nor clinical symptoms occurred. Development of body weight was not impaired. The animals were killed at the end of the observation period of 14 days and showed no macroscopically visible changes.

Acute oral toxicity testing to B-TEGME in the Wistar rat yielded a median lethal dose level above 2000 mg/kg body weight in both male and female animals.