Reaction Product of Rosin, fumarated, Tall-Oil Rosin, Ca(OH)2 and MgO

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 422

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated

EC Number:

266-040-8

EC Name:

Rosin, fumarated

Cas Number:

65997-04-8

IUPAC Name:

Rosin, fumarated

Details on test material:

- Name of test material (as cited in study report): Rosin, fumarated
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: UVCB, distillation products
- Physical state: amber solid
- Analytical purity: normal commercial sample
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: TWR01075-15FTOR-9.19.01
- Expiration date of the lot/batch: 21 September 2006
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: in the dark at room temperature.
- Other:

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: (P) 6 x wks on arrival;
- Weight at study initiation: on arrival (P) Males: 140-169 g; Females: 111-138 g;
- Fasting period before study: none
- Housing: 2 per cage initially, in polypropylene cages, with stainless steel grid bottoms and mesh tops. A few days prior to pairing for mating, males were transferred to individual cages of similar design. Mated females were transferred to individual solid bottomed cages.
- Use of restrainers for preventing ingestion (if dermal): n/a
- Diet (e.g. ad libitum): Ad libitum. Rat and Mouse Breeder Diet No. 3 (Expanded Ground) SQC, (Special Diets Services Ltd., Essex, UK)
- Water (e.g. ad libitum): Ad libitum, domestic mains water.
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20+/-2
- Humidity (%):50+/-15
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: diet

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly and used within 15 days of preparation
- Mixing appropriate amounts with (Type of food): Rat and Mouse Breeder Diet No. 3 (Expanded Ground) SQC
- Storage temperature of food: No data.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Diet formulations were analysed on 2 occasions during the study treatment period. Analysis of formulated diets was undertaken with regard to concentration and homogeneity.
Diet prepared for Week 1 and Week 4 of treatment was sampled. On each occasion, triplicate samples were withdrawn from each formulated diet containing test item, and from the Control diet. The samples were analysed by the Toxicology Support Laboratory, using a method supplied by the sponsor and previously validated in the laboratory.

Duration of treatment / exposure:

Males: at least 4 weeks overall, starting from 2 weeks prior to mating until termination.
Females: commencing 2 weeks prior to mating, then through mating until termination after Day 4 of lactation.

Frequency of treatment:

continuous

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 ppm
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
1000 ppm
Basis:
nominal in diet

Doses / concentrations 3

Remarks:

Doses / Concentrations:
3000 ppm
Basis:
nominal in diet

Doses / concentrations 4

Remarks:

Doses / Concentrations:
10000 ppm
Basis:
nominal in diet

No. of animals per sex per dose:

10

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: Dose levels selected and agreed with Sponsor, following evaluation of existing toxicological data. This included data from a one week dose range finding study in rats carried out under a separate contract and project number at the laboratory.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

1

Dose descriptor:

NOEL

Effect level:

1 000 ppm (nominal)

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOEL

Effect level:

3 000 ppm (nominal)

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified