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EC number: 923-201-3 | CAS number: 1192143-92-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- UMA121
- IUPAC Name:
- UMA121
- 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
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks (males), 12 - 13 weeks (females)
- Weight at study initiation: 256 - 278 g (males), 211 - 224 g (females)
- 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:
From: 16 Aug 2012
To: 30 Aug 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped, healthy skin of the dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap if used: gauze and non-irritant tape, fixed with a semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After an exposure period of 24 h, the residual test substance was removed using the vehicle. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- 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. The animals were weighed on Day 1 prior to application and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: primary skin irritation (Draize scoring system)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- other: No signs of sytemic toxicity were observed.
- Gross pathology:
- The necropsy revealed no test substance-related findings.
- Other findings:
- Skin irritation:
No erythema and oedema formation was noticed during the observation period. In 1/5 males, eschar formation was observed on Day 8, that resolved within 24 h (Table 2). In 4/5 females, scratches, eschar formation or wounds were noticed which were fully reversible within the observation period in 3/5 females (Table 3).
Any other information on results incl. tables
Table 1: Absolute Body Weights and Body Weight Gain
Animals |
Body weight (g) |
Increase (%) |
|||
Sex |
Number |
Day 1 |
Day 8 |
Day 15 |
Day 1 - 15 |
male |
21 |
274 |
305 |
339 |
24 |
22 |
264 |
285 |
310 |
17 |
|
23 |
256 |
255 |
273 |
7 |
|
24 |
278 |
291 |
319 |
15 |
|
25 |
270 |
281 |
313 |
16 |
|
female |
26 |
213 |
213 |
219 |
3 |
27 |
224 |
221 |
221 |
-1 |
|
28 |
211 |
215 |
216 |
2 |
|
29 |
212 |
206 |
211 |
0 |
|
30 |
213 |
211 |
215 |
1 |
|
Table 2: Skin irritation – individual data – males
Days after Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
2 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
3 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
4 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
5 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
6 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
7 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
8 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es |
0/0 |
nsf |
0/0 |
nsf |
9 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
10 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
11 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
12 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
13 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Comments:
E = erythema, O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Draize scoring system)
es = eschar, s = scratches, es* = eschar on large patches; w = small wounds; w (2) = wound (2 mm diameter) nsf = no specific finding
Table 3: Skin irritation – individual data – females
Days after Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
2 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
3 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
4 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
5 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es* |
0/0 |
es |
6 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
es* |
0/0 |
es |
7 |
0/0 |
s |
0/0 |
s |
0/0 |
nsf |
0/0 |
es* |
0/0 |
nsf |
8 |
0/0 |
w (2) |
0/0 |
es |
0/0 |
nsf |
0/0 |
es* |
0/0 |
nsf |
9 |
0/0 |
w (2) |
0/0 |
es |
0/0 |
nsf |
0/0 |
es* |
0/0 |
nsf |
10 |
0/0 |
w (2) |
0/0 |
es |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
11 |
0/0 |
w (2) |
0/0 |
es |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
12 |
0/0 |
w (2) |
0/0 |
es |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
13 |
0/0 |
w |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
14 |
0/0 |
w |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
w |
0/0 |
nsf |
Comments:
E = erythema, O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Draize scoring system)
es = eschar, s = scratches, es* = eschar on large patches; w = small wounds; w (2) = wound (2 mm diameter) nsf = no specific finding
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
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