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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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
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
Based on:
test mat.
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
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test the dermal LD50 of TEA in the rabbit is higher than 2000 mg/kg bw.
Executive summary:

In this dermal limit test, rabbits were treated with 2000 mg/kg bw TEA on the intact or abraded skin and subsequently observed for a 14 -day period (EPA, 1989a). The test substance was either derived from NH3 (92% TEA) or DEA (88% TEA), both containing approximately 6.5% DEA. Mild erythema was observed following exposure to TEA derived from NH3 on the intact or abraded skin, returning to normal on day 6. Moderate erythema was observed following exposure to TEA derived from DEA on the intact or abraded skin, returning to normal on day 10. No mortality was observed, hence the LD50 was > 2000 mg/kg bw.