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Toxicological information

Acute Toxicity: dermal

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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:
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:
EPA OTS 798.1100 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
Nine out of ten of the animals exhibited slight to defined Erythema. One rabbit also exhibited Edema at the 24 hour scoring.
Body weight:
no effects
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.