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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
06. Jun. 2005 - 22. Jun. 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Species: rat
Breed: White Wistar
Breeder: Harlan Winkelmann, Borchen, Germany
Date of receipt: 2005-05-31
Number / Sex: 12 female
Body weights: 159.9 - 180.7 g at day of application
Age: about 8 weeks at day of application
Identification: dye marks and cage numbers
Diet: Altromin International, Lage, Germany, Type 1324 - 1188,
Water: Drinking water consisted of normal tap water from municipal sources (Stadtische Werke Krefeld AG, Krefeld, Germany). The water was monthly examined for pollutants which might interfere with the study. The data are retained in the archive.
Bedding material: Lignocel BK 10/20, Rettenmaier & Sohne GmbH & Co., Batch 02101 40915
Experimental animals:
Young healthy rats acclimatized for at least 5 days to laboratory conditions were used for this test. During the acclimatization period animals were observed for their health condition to assure that they were in best condition for this investigation. Only female rats were used.
Husbandry:
Three rats were housed in one Makrolon cage type VI each. A non-barrier system with air condition was used. The air conditioning had following nominal values: Temperature: 22°C ± 3°C, Humidity: 30 - 70 %. Climate control was run automatically. The lighting was in a 12-hour light/dark-cycle. Temperature and humidity were recorded continuously using a thermohygrometer, Lambrecht GmbH, Gottingen, Germany. The data were archived. There has been a deviation from nominal humidity values. On 2005-06-17 and 2005-06-18 the humidity was slightly higher (up to 75 %). However, this deviation is not supposed to have any effect on the experimental result.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The starting dose of 300 mg/kg body weight was applied to six female animals as 10 % (w/w) solution in tap water. Therefore 1.5 g of the test substance were added to 13.5 g tap water and mixed on a magnetic stirrer. The density of the 10 % solution was 1.025 g/mL and of the undiluted test substance 1.22 g/mL. The density of the undiluted test substance was higher than 1.05 g/mL and therefore was considered in calculation of the application volume. The dose of 2000 mg/kg body weight was applied to six female animals with the undiluted test substance.
Dose volume: 300 mg/kg group: 0.48 - 0.51 mL; 2000 mg/kg: 0.27 - 0.30 mg/kg.
Doses:
300 mg/kg, 2000 mg/kg
No. of animals per sex per dose:
6 animals per dose (female only)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examination was performed immediately, 0.5, 1.5 and 3.5 hours after test substance administration and thereafter daily; weighing at day 0, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Based on:
other: solid matter (incl. NaCl)
Sex:
female
Dose descriptor:
LD50
Effect level:
> 830 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: test substance Formamidopropyldimethylbetain 50 %ig (50 %ig based on solid matter, active matter: 41.5 %)
Mortality:
No mortality occured.
Clinical signs:
No clinical signs observed
Body weight:
The body weight development of the animals was positive and within normal ranges.
Gross pathology:
The necropsy 14 days after application showed no substance related morphological visible pathologic organ findings.

Any other information on results incl. tables

Body weights

Animal ID

Sex

Dose [mg/kg]

Day 0 [g]

Mean±SD

Day 7 [g]

Mean±SD

Day 14 [g]

Mean±SD

Average weight gain [%]

425

F

300

168.4

165.6 ±3.8

190.7

186.0 ±9.6

197.6

198.0 ±7.6

+ 19.6

425 RV

F

300

166.8

183.8

197.7

425 RH

F

300

161.6

171.0

185.7

426

F

300

169.2

183.3

201.1

426 RV

F

300

159.9

187.2

196.8

426 RH

F

300

167.4

200.0

209.3

427

F

2000

173.7

171.2 ±5.8

196.0

191.7 ±8.6

208.7

204.7 ±6.1

+ 19.6

427 RV

F

2000

165.4

180.0

197.3

427 RH

F

2000

166.4

185.3

198.0

428

F

2000

180.7

204.3

212.9

428 RV

F

2000

167.9

189.8

205

428 RH

f

2000

173.0

194.7

205.9

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The LD50-value of the test substance Formamidopropyldimethylbetain (41.5% a.i.) is greater than 2000 mg/kg body weight, corresponding to >830 mg/kg bw in terms of active substance.
Executive summary:

The test substance Formamidopropyldimethylbetain (50% based on solid matter, active matter: 41.5%) is a clear yellowish liquid. For labelling and classification purposes the test substance was tested regarding its acute toxic potential following oral application. Slight acute oral toxicity of the test substance was expected. Therefore the starting dose of 300 mg/kg body weight was chosen in the Acute-Toxic-Class-Method procedure, according to the OECD Guideline for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method". A total of twelve female rats of the strain White Wistar were used in the study. The test substance was applied by gavage undiluted and as 10% (w/w) solution in tap water. No toxic symptoms after administration of 300 mg/kg body weight were observed in six animals. In the next step the test substance was applied to six rats at a dose level of 2000 mg/kg body weight. No toxic symptoms were observed in this group, as well. No death occurred in all groups of the dose levels 300 mg/kg and 2000 mg/kg body weight. Body weight development of all animals was positive 7 days and 14 days post application. The necropsy 14 days after oral application showed no substance related morphological visible pathologic organ findings. Thus, the LD50-value for the test substance is higher than 2000 mg/kg bw, corresponding to > 830 mg/kg bw in terms of active substance. Therefore, the test substance Formamidopropyldimethylbetain 50% does not need to be classified according to the Globally Harmonised System.