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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
16 September 1987 to 27 October 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, data on test substance and test system sparse

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
data on test substance and test system sparse
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
data on test substance and test system sparse
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Dresinate 835 A
IUPAC Name:
Dresinate 835 A
Constituent 2
Reference substance name:
Dresinate 731
IUPAC Name:
Dresinate 731
Constituent 3
Reference substance name:
Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate
IUPAC Name:
Reaction mass of Resin acids and Rosin acids, hydrogenated, sodium salts and sodium [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate
Details on test material:
- Name of test material (as cited in study report): Dresinate 731

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 177 - 202 g (males), 179 - 185 g (females)

IN-LIFE DATES: From: 17 September 1987 To: 15 October 1987

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionised water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 16, 20 and 22.4 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION:
The test item was dissolved in deionised water at the quantities requeired and was homogeneously ditributed by the aid of a magnetic stirrer.
Doses:
males: 1600, 2000 and 2240 mg/kg bw
females: 2000 mg/kg bw
No. of animals per sex per dose:
1600 mg/kg bw: 5 m
2000 mg/kg bw: 5 m + 5f
2240 mg/kg bw: 5 m
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
--- animal observations 10 and 30 min and 1, 2, 4 and 6 hours p.a. and once daily thereafter until termination
--- nody weights: on days 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 130 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Mortality:
1600 mg/kg bw: 0/0 males
2000 mg/kg bw: 2/5 males, 1/5 females
2240 mg/kg bw: 3/5 males
Clinical signs:
other: activity decreased, retracted flanks, hunched posture in animals of all groups; symptoms observed from 2 hours p.a. until 4 days p.a.
Gross pathology:
Deceded animals: blood congestion (lungs), dark liver, GIT filled with test substance, dark adrenals
Survivors, killed at study termination: nothing abnormal detected
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (oral, rat) was 2130 mg/kg body weight for males and >2000 mg/kg body weight for females. Mortaility occurred already at 2000 mg/kg bw in males (40 % of the respective animals).
Executive summary:

The test substance was dissolved in deionised water and was administered orally per gavage to 3 groups of 5 males each and to one group of 5 females. The doses used were: 1600, 2000 and 2240 mg/kg body weight for males and 2000 mg/kg bw for females. The animals were observed for clinical signs up to 14 days p.a. Body weights were determined 0, 7 and 14 days p.a. All animals were necropsied and subjected to a gross macroscopic examination.

Results:

Mortality occurred at 2000 mg/kg bw (2/5 males, 1/5 females) and at 2240 mg/kg bw (3/5 males). No mortality occurred at 1600 mg/kg bw. The calculated LD50 (probit analysis) was 2130 mg/kg bw.