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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database.

Data source

Referenceopen allclose all

Reference Type:
other: authoritative database
Title:
Acute dermal toxicity study of Terephthalic acid (100-21-0) in rabbit.
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
HSDB (Hazardous Substances Data Bank), US national Library of Medicine, 2017.
Reference Type:
secondary source
Title:
IUCLID Dataset of CAS 100-21-0
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
IUCLID Dataset, EUROPEAN COMMISSION – European Chemicals Bureau, 22 - FEB - 2000.
Reference Type:
secondary source
Title:
SIDS Initial Assessment Profile for Terephthalic acid.
Author:
United Nations Environmental Programme (UNEP)
Year:
2001
Bibliographic source:
SIDS Initial Assessment Profile for Terephthalic acid, United Nations Environmental Programme (UNEP), 2001.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute Dermal Toxicity Study of 1,4-Benzenedicarboxylic acid (100-21-0) in Rabbits.
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 - 1,4-Benzenedicarboxylic acid
InChI - 1S/C8H6O4/c9-7(10)5-1-2-6(4-3-5)8(11)12/h1-4H,(H,9,10)(H,11,12)
Smiles - c1(C(O)=O)ccc(C(O)=O)cc1
- Name of test material (as cited in study report):Terephthalic acid
- Molecular formula (if other than submission substance):C8H6O4
- Molecular weight (if other than submission substance):166.131 g/mole
- Substance type:Organic
- Physical state:Solid
- Purity: >99%
- Impurities (identity and concentrations):<1%
Specific details on test material used for the study:
Name - 1,4-Benzenedicarboxylic acid
InChI - 1S/C8H6O4/c9-7(10)5-1-2-6(4-3-5)8(11)12/h1-4H,(H,9,10)(H,11,12)
Smiles - c1(C(O)=O)ccc(C(O)=O)cc1
- Name of test material (as cited in study report):Terephthalic acid
- Molecular formula (if other than submission substance):C8H6O4
- Molecular weight (if other than submission substance):166.131 g/mole
- Substance type:Organic
- Physical state:Solid
- Purity: >99%
- Impurities (identity and concentrations):<1%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: about 3 months
- Weight at study initiation: Animals were weighed an average of 2.59 kg (Male) and 2.45 kg (Female).

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The test material was applied on the back
- Type of wrap if used: Covered with an occlusive wrap.
Duration of exposure:
No data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total = 10 (5/sex)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily for Mortality and general symptoms; Body weights were assessed at dosing, and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs.
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality observed at 2000 mg/kg bw.
Clinical signs:
Clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females. All animals appeared normal by Day 4.
Body weight:
Mean body weights increased during the study.
Gross pathology:
No alterations were noted during gross necropsy.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be >2000 mg/kg bw, when Male and female New Zealand rabbits were treated with 1,4-Benzenedicarboxylic acid (100-21-0) occlusively to the skin.
Executive summary:

Acute dermal toxicity study was conducted in 10 Male and female New Zealandrabbits using 1,4-Benzenedicarboxylic acid (100-21-0) at the concentration of 2000mg/kg bw.The test material (Terephthalic acid was supplied by the Amoco Corporation; Purity exceeds 99%) wasapplied on the back and covered with an occlusive wrap.Prior to application, the backs were shaved and moistened with water.Animals were observed daily for Mortality and general symptoms; Body weights were assessed at dosing, and on Days 7 and 14.No mortality observed at 2000 mg/kg bw. Clinical signs noted consisted of an erythema at the application site immediately after unwrapping in 2/5 males and 4/5 females. All animals appeared normal by Day 4. Mean body weights increased during the study. No alterations were noted during gross necropsy. Therefore, LD50 was considered to be >2000 mg/kg bw, when Male and female New Zealand rabbits were treated with 1,4-Benzenedicarboxylic acid occlusively to the skin..