2-amino-2-methylpropane-1,3-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reporting is limited, but sufficient information to judge the hazard potential

Justification for type of information:

See attached (in chapter 13 of IUCLID) document with the justification for the category/read-across approach.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Oral toxicity: key study in rats using APD (category member), 3 supporting studies from Category Members (AEPD and AMPD)
Dermal: key study in rabbits conducted on APD, one supporting study from category member AEPD

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Endpoint conclusion:

no study available

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Oral toxicity:

The acute oral toxicity of the members of this category is low. All oral LD50 values in rats are >2000 mg/kg bw. Clinical signs observed in the available studies include lethargy and hunched posture, consistent with discomfort. Gross pathologial signs were consistent with the high pH of these materials (discoloration of the intestines and signs of hemorrhaging in the stomach). Value taken forward to CSR for acute oral toxicity of APD: LD50 >5000 mg/kg bw.

Dermal toxicity:

The acute dermal toxicity of the members of this category is low. The LD50 values from studies in rabbits are >2000 for APD and AEPD. Given the structural similarity it is assumed that the dermal toxicity of AMPD will be consistent with the other members of the category, and therefore also >2000 mg/kg bw. In the available studies, there were no clinical signs of toxicity other than some local effects (erythema/odema) immediatly following dosing. These subsided by the end of the study.

Value taken forward to CSA for APD: dermal LD50 >2000 mg/kg bw

Inhalation toxicity:

No studies are available for the substances in the category. However given the low toxicity via oral and dermal routes it is considered unlikely that these would pose an acute inhalation toxicity hazard. In addition, the vapour pressure of these substances is low, limiting the potential for an acute inhalation exposure to occur.

The LD50 values for oral and dermal routes are >2000 mg/kg bw, therefore no classification for acute toxicity is required according to DSD or CLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-aminopropane-1,3-diol

EC Number:

208-584-0

EC Name:

2-aminopropane-1,3-diol

Cas Number:

534-03-2

Molecular formula:

C3H9NO2

IUPAC Name:

2-amino-1,3-propanediol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Serinol (APD-1,3)

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2g/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Nine out of ten of the animals exhibited slight to defined Erythema. One rabbit also exhibited Edema at the 24 hour scoring.

Gross pathology:

no effects

Other findings:

none

Any other information on results incl. tables

None of the test animals exhibited clinical signs of toxicity and all animals gained weight during the course of the study. Nine out of ten of the animals exhibited slight to defined Erythema. One rabbit also exhibited Edema at the 24 hour scoring. There were no visible lesions noted in any test animals upon gross observation at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is considered non-toxic according to the procedures listed in the TSCA guidelines, 40 CFR, Part 798.