Pyridine-2,4-dicarboxylic acid

Acute Toxicity: dermal

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

Reference

Reference 1

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 2

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 3

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

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

Test material information

Constituent 1

Reference substance name:

Terephthalic acid

EC Number:

202-830-0

EC Name:

Terephthalic acid

Cas Number:

100-21-0

Molecular formula:

C8H6O4

IUPAC Name:

benzene-1,4-dicarboxylic acid

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 or test system 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..