Butane-1,2,3,4-tetracarboxylic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from NTP and NTRL report.

Justification for type of information:

Data is from NTP and NTRL report.

Data source

Reference

Reference 1

Reference Type:

other: Authoritative database.

Title:

Study of Inhalation Toxicity in rats.

Author:

Arthur D. Little, Inc.

Year:

1991

Bibliographic source:

NATIONAL TOXICOLOGY PROGRAM, EXECUTIVE SUMMARY OF SAFETY AND TOXICITY INFORMATION, 4 October 1991

Reference 2

Reference Type:

secondary source

Title:

Inhalation Toxicity in rats.

Author:

Mallinckrodt INC

Year:

1980

Bibliographic source:

NTIS Report, OTS02800059

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To access the effect of Butane-1,2,3,4-tetracarboxylic acid in rats.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,2,3,4-tetracarboxylic acid

EC Number:

216-938-0

EC Name:

Butane-1,2,3,4-tetracarboxylic acid

Cas Number:

1703-58-8

Molecular formula:

C8H10O8

IUPAC Name:

butane-1,2,3,4-tetracarboxylic acid

Test material form:

solid

Details on test material:

- Name of the test chemical: Butane-1,2,3,4-tetracarboxylic acid- IUPAC name: Butane-1,2,3,4-tetracarboxylic acid - Molecular Formula: C8H10O8- Molecular Weight: 234.159 g/mol- Smile Notation: OC(=O)C[C@H]([C@H](CC(=O)O)C(=O)O)C(=O)O- InChI : 1S/C8H10O8/c9-5(10)1-3(7(13)14)4(8(15)16)2-6(11)12/h3-4H,1-2H2,(H,9,10)(H,11,12)(H,13,14)(H,15,16)/t3-,4+- Substance type: organic

Specific details on test material used for the study:

Name of the test chemical: Butane-1,2,3,4-tetracarboxylic acidMolecular Formula: C8H10O8Molecular Weight: 234.159 g/molSmile Notation: OC(=O)C[C@H]([C@H](CC(=O)O)C(=O)O)C(=O)OInChI : 1S/C8H10O8/c9-5(10)1-3(7(13)14)4(8(15)16)2-6(11)12/h3-4H,1-2H2,(H,9,10)(H,11,12)(H,13,14)(H,15,16)/t3-,4+Substance type: organic Physical state: Solid

Test animals

Species:

rat

Strain:

other: COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: No dataAge at study initiation: No dataWeight at study initiation:198-293gmFasting period before study: yes, overnight fasting Housing: Metal wire bottomed cagesDiet (e.g. ad libitum): Purina Rodent Laboratory Chow, ad libitiumWater (e.g. ad libitum):Tap water, ad libitium Acclimation period: No data

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

other: dust

Details on inhalation exposure:

- Weight at study initiation:Animal NoSexInitial weight(g)1M2562M2563M2464M2575M2726F2427F2418F2519F23010F251- Fasting period before study: No- Housing: Metal Wire Bottomed cages- Diet (e.g. ad libitum): Purina Rodent Laboratory Chow(pellitized),ad libitium- Water (e.g. ad libitum):tap water, ad libitum- Acclimation period: Not dataENVIRONMENTAL CONDITIONS- Temperature (°C): Not data- Humidity (%): Not data- Air changes (per hr):Not data- Photoperiod (hrs dark / hrs light): Not data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

1 h

Remarks on duration:

60 minutes (plus a 23 minute equilibration period).

Concentrations:

1.7 grams of the substance

No. of animals per sex per dose:

5 animals per sex

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?): 14 day observation period- Frequency of observations and weighing: 1 day, 7 day and 14 day- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: body weight and lung observations

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

8.19 other: mg

Based on:

test mat.

Exp. duration:

1 h

Remarks on result:

other: LC 0 value was observed

Mortality:

No mortality was observed

Clinical signs:

other: No data available

Body weight:

Body weight showed weight gain within the expected limits.

Gross pathology:

moderate congestion of the lungs in three of the ten animals were observed. It is not possible to assign acause effect relation to the lung congestion, but this type of congestion is often observed as a sacrifice artifact in rats.

Applicant's summary and conclusion

Interpretation of results:

other:

Conclusions:

At a flow concentration of approximately 8.19 mg per liter of air and flow rate of 2.5 liters per minute for a period of 60 minutes plus 23 minutes equilibration time, all of the test animals survived. The LD50 for butane tetracarboxylic acid >8.19 mg/lt of air.

Executive summary:

Ten albino rats (five male and five female, COX-SD strain), weighing 230 to 272 grams, were exposed by the route of inhalation to undiluted butane tetracarboxylic acid in the powder form at a delivery flow concentration of approximately 8.19 mg per liter of air at a flow rate of 2.5 liters per minute for a period of 60 minutes plus 23 minutes for equilibration. All of the animals survived the 60 minute exposure and the 14 day observation period which followed. Body weight gain was observed.No sign of gross toxicity was observed in any animal after post exposure observation period. 3 of the 10 animals shows lung congestion and other animals were not remarkable.

On the basis of observation,the LD 50 value for butane tetracarboxylic acid was considered to be >8.19 mg/l of air concentations.