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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Test material was applied under an impervious cuff held in place with rubber bands and covered with a cloth bandage taped to the marginal hair. Following a 24-hour exposure period the cuffs were removed and the skin was washed with soap and water. Observations were made at this time for erythema, edema and necrosis. All animals were observed for signs of toxicity during and after exposure and were weighed at intervals up to two weeks post-application or, when practical, until any weight loss has been regained and the animals appear healthy.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1',1''-nitrilotripropan-2-ol
EC Number:
204-528-4
EC Name:
1,1',1''-nitrilotripropan-2-ol
Cas Number:
122-20-3
Molecular formula:
C9H21NO3
IUPAC Name:
1,1',1''-nitrilotripropan-2-ol
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
female
Details on test animals or test system and environmental conditions:
Male or female New Zealand albino rabbits (Langshaw Farms, Augusta, Michigan) were obtained. Twenty four hours prior to use the hair is removed from the entire trunks of New Zealand albino rabbits with electric clippers.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Test material was applied under an impervious cuff held in place with rubber bands and covered with a cloth bandage taped to the marginal hair. Following a 24-hour exposure period the cuffs were removed and the skin was washed with soap and water. Observations were made at this time for erythema, edema and necrosis. All animals were observed for signs of toxicity during and after exposure and were weighed at intervals up to two weeks post-application or, when practical, until any weight loss has been regained and the animals appear healthy.
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
2 females
Control animals:
no
Details on study design:
Test material was applied under an impervious cuff held in place with rubber bands and covered with a cloth bandage taped to the marginal hair. Following a 24-hour exposure period the cuffs were removed and the skin was washed with soap and water. Observations were made at this time for erythema, edema and necrosis. All animals were observed for signs of toxicity during and after exposure and were weighed at intervals up to two weeks post-application or, when practical, until any weight loss has been regained and the animals appear healthy.
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no mortality was observed at 5000 mg/kg.
Clinical signs:
Twenty four hours after application of the test material, moderate erythema was noted in both rabbits, slight edema and necrosis was observed in one rabbit.
Body weight:
Both rabbits gained weight
Gross pathology:
no data
Other findings:
no additonal findings

Any other information on results incl. tables

Both rabbits survived the two-week observation period. No signs of toxicity were observed in the rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Both rabbits survived the two-week observation period. No signs of toxicity were observed in the rabbits. The dermal LD50 is >5000 mg/kg.
Executive summary:

A sample of triisopropanolamine, also known as TIPA, was submitted for acute toxicological evaluation and definition of industrial handling hazards. Toxicity tests were conducted on this material as an 85% solution in distilled water. This is the final use dilution. Eye, skin irritation and acute percutaneous absorption tests were conducted on male or female New Zealand albino rabbits (Langshaw Farms, Augusta, Michigan).

The potential of this material to produce systemic toxicity when absorbed through the skin is low. In the acute percutaneous absorption test 2 rabbits received 5000 mg/kg of the material as an 85% aqueous solution; both rabbits survived the two-week observation period. No signs of toxicity were observed in the rabbits.