Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
end on 13-SEP-2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Uronium hydrogen sulphate
EC Number:
244-343-6
EC Name:
Uronium hydrogen sulphate
Cas Number:
21351-39-3
IUPAC Name:
amino(hydroxy)methaniminium hydrogen sulfate
Details on test material:
- Name of test material (as cited in study report): aduct urea-sulfuric
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: dry, ventilated well, away from inflammable materials

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH (Sulzfeld)
- Age at study initiation: no data
- Weight at study initiation: 224 - 268 g
- Fasting period before study: no
- Housing: transparent macrolone cages with two or three in each cage, males and females separated
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70%
- Air changes: 10 times / hour
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: From June 22th to July 28th 2010

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank
- % coverage: 6 x 8 cm
- Type of wrap if used: 4-layer gauze pack, fixed with Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (ca. 1.3 ml/kg bw)
- Concentration: undiluted
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> observations: each rat was observed 1, 3 and 6 hours after the start of the application and thereafter once daily
> Body weight: on days 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
Neither female nor male rats died on account of the treatment or showed severe sign of toxicosis.
Clinical signs:
All animals showed piloerection on day 0 after 1 hours and normal behaviour after 3 hours as well as 6 hours. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
Body weight:
The rats had a normal body weight gain during the study period.
Gross pathology:
The post mortem inspection revealed no pathological abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 > 2000 mg/kg bw in rats
Executive summary:

In an acute dermal toxicity study (OECD 402, GLP), a group of Wistar rats (5/sex) was dermally exposed to undiluted uronium hydrogen sulphate for 24 hours at the dose of 2000 mg/kg bw. Animals then were observed for 14 days.

 

Dermal LD50 (Males/Females) > 2000 mg/kg bw (no mortality observed)

 

No effects were observed on mortality, body weight gain and gross pathology.

No clinical signs were observed, except at 1 hour after application (piloerection in all animals).

 

Based on this study, uronium hydrogen sulphate is of low toxicity and is not classified as dangerous for acute dermal toxicity according to EU criteria (DSD or CLP).