Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
date of report: July 30, 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
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): Triethanolamine derived from NH3 and Triethanolamine derived from DEA
- Lot-No.: TEA from NH3: jefferson 50303 and TEA from DEA: 2H1763
- Analytical purity: TEA derived from NH3: 91.8 %;
- Analytical purity: TEA derived from DEA: 88.1 %;
- Impurities: both test substances contain DEA as a major impurity of about 6.5 %, the DEA derived test substance additionally includes TEA-1EO at 4.4 %

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
intact and abraded skin was tested
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 animals tested with intact skin and 3 animals tested with abraded skin with DEA-derived and NH3-derived TEA each (12 animals in total)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
TEA derived from NH3 (intact): 0/3
TEA derived from NH3 (abraded): 0/3
TEA derived from DEA (intact): 0/3
TEA derived from DEA (abraded): 0/3
Clinical signs:
TEA derived from NH3: mild erythema at 24 hrs (intact and abraded skin) returning to normal on day 6
TEA derived from DEA: moderate erythema at 24 hrs (intact and abraded skin) returning to normal on day 10
Body weight:
all animals showed body weight gain during the course of the study

Applicant's summary and conclusion