Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Each of six albino rabbits was treated dermally with 2000 mg/kg (2.24 mL/kg). Individual doses were applied to the hair-clipped skin of the trunk under a pre-fitted occluding sleeve on each animal. The sleeves were removed 24 hours later and the animals were observed for 7 days.
GLP compliance:
no
Test type:
other: 6 albino rabbits were treated dermally with 2000 mg/kg
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylmonoethanolamine
- Substance type: organic (alkanolamine)
- Physical state: liquid (clear colourless, D = 0.893 g/mL)

Test animals

Species:
rabbit
Strain:
other: the only information given: albino rabbits
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: a pre-fitted occluding sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
2000 mg/kg (=2.24 mL/kg bw)
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: each of the treated animals remained asymptomatic and gained body weight during the observation period.
Mortality:
no mortality
Clinical signs:
the animals remained asymptomatic
Body weight:
the animals gained body weight during the observation period
Gross pathology:
no data
Other findings:
no other findings reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects were observed in treated animals after 24-hour dermal application of 2000 mg/kg bw of test material.
Executive summary:

Each of six albino rabbits was treated dermally with 2000 mg/kg (2.24 mL/kg). Individual doses were applied to the hair-clipped skin of the trunk unter a pre-fitted occluding sleeve on each animal. The sleeves were removed 24 hours later and the animals were observed for 7 days. Each of the treated animals remained asymptomatic and gained body weight during the observation period. Based on the results of the study, The LD0 of the test material is greater than 2000 mg/kg bw.