2-Propenoic acid, 2-methyl-, monoester with 1,2-propanediol, reaction products with dipropylene glycol and 1,1'-methylenebis[isocyanatobenzene]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

UMA121

IUPAC Name:

UMA121

Constituent 2

Reference substance name:

Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked

EC Number:

923-201-3

Cas Number:

1192143-92-2

Molecular formula:

C29H34N2O8 C50H58N4O13 C71H82N6O18 C92H106N8O23 C113H130N10O28

IUPAC Name:

Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked

Test animals

Species:

rat

Strain:

other: Wistar Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 154 - 167 g
- Fasting period before study: Food was withheld for 16 to 19 h before until 4 h after dosing.
- Housing: The animals were housed in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
- Step 1
From: 27 Jul 2012
To: 10 Aug 2012
- Step 2
From: 16 Aug 2012
To: 30 Aug 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3/step)

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made several times on the day of dosing (especially during the first 30 min until 4 h after application) and once daily thereafter until the end of the study period. Animals were weighed on Days 1, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: cut-off value

Mortality:

All animals survived until the end of the observation period.

Clinical signs:

other: After application of the test substance, slightly reduced spontaneous activity and slight piloerection were noticed in all animals. The effects were reversible within 4 h. Moreover, the first set of animals showed bradykinesia, kyphosis and half eyelid-cl

Gross pathology:

Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Absolute Body Weights and Body Weight Gain

Animals		Body weight (g)			Increase (%)
Step	Number	Day 1	Day 8	Day 15	Day 1 - 15
1	1	156	187	198	27
	2	154	176	185	20
	3	165	175	200	21
2	4	164	191	208	27
	5	167	189	202	23
	6	164	185	197	20

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified