Rosin, fumarated, reaction products with formaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study to OECD protocol and subject to GLP audit.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts

IUPAC Name:

Fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts

Constituent 2

Reference substance name:

Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts

EC Number:

500-451-8

EC Name:

Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts

Cas Number:

160901-14-4

IUPAC Name:

160901-14-4

Details on test material:

- Name of test material (as cited in study report): Fatty acids, tall ouil, oligomeric product with maleic acid and rosin, calcium, magnesium, zinc salt
- Substance type: Chemically modified UVCB
- Physical state: Yellow-orange solid
- Analytical purity: 100%
- Lot/batch No.:KB 901684
- Expiration date of the lot/batch: 5 June 2010

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

six

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

No

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts is greater than 2000 mg/kg bw by the oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of Fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.

In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category.

Executive summary:

In an acute oral toxicity study, a single dose fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts was administered via gavage to six female rats were at a concentration of 2000 mg/kg. One animal died prior to study termination. The only effects seen in the surviving animals were decreased spontaneous activity and piloerection in one animal at 24.5 h post dose. Body weight gain was normal and there were no macroscopic abnormalities at post mortem on completion of the study.The acute oral LD50 in this study was >2000 mg/kg bw for female rats.