Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-04-29 to 2014-05-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tris(2-hydroxyethyl)methylammonium methyl sulphate- Substance type: organic- Physical state: yellowish liquid- Expiration date of the lot/batch: July 2015- Storage condition of test material: Room temperature; avoid temperatures < 5 °C and > 30 °C- Analytical purity: 98.9 %- Lot/batch No.: Lot. 29734916K0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River Wiga GmbH, Germany- Age at study initiation: males approx. 8 weeks old, females approx. 12 weeks old- Weight at study initiation: 235 g (mean, males); 207.4 g (mean, females)- Fasting period before study: no- Housing: individually in Makrolon cage, type III- Diet: ad libitum (H 15005-29; Ssniff, Spezialitaeten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)- Water: ad libitum (tap water)- Acclimation period: at 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30-70- Air changes (per hr): 10- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE- Area of exposure: dorsal and dorsolateral parts of the trunk- % coverage: at least 10 % of the body surface- Type of wrap if used: Stretch bandageREMOVAL OF TEST SUBSTANCE- Washing (if done): with warm water- Time after start of exposure: 24 hoursTEST MATERIAL- Amount(s) applied: 1.47 mL/kg bw- Concentration: undiluted- Constant volume or concentration used: no
Duration of exposure:
24 hours
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: daily, weighing was performed weekly- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurre during the study.
Clinical signs:
No systemic clinical signs were observed during clinical examination in male and female animals. All male animals revealed very slight erythema (grade 1) on study day 1. In four female animals very slight erythema (grade 1) was noted on study day 1, while in the fifth animal very slight erythema was observed from study day 1 until day 3. In addition scaling was observed in this animal from day 2 until day 6 and incrustations on day 6 only.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period with one exception. In one male animal the body weight decreased during the second week, but this occurred without any clinical symptoms or any change in behavior.The body weight of the female animals only slightly increased or stagnated during the first observation week, probably due to the bandage procedure, but increased within the normal range during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information