Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
long-term toxicity to fish, other
Remarks:
Calculation method
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
From 2019-03-06 to 2019-03-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Not applicable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Deviations:
yes
Remarks:
QSAR model
Principles of method if other than guideline:
The chronic toxicity to fish was determined using a validated QSAR for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (Bauer et al., 2018). The QSAR is based on validated data for a training set of 27 chemicals derived from 32-day test on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene; 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene; 3-methylidene-6-(propan-2-yl)cyclohex-1-ene; 6,6-dimethyl-2-methylidenebicyclo[3.1.1]heptane; 7-methyl-3-methylideneocta-1,6-diene
EC Number:
932-349-8
Cas Number:
8006-64-2
Molecular formula:
C10H16
IUPAC Name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene; 3,7,7-trimethylbicyclo[4.1.0]hept-3-ene; 3-methylidene-6-(propan-2-yl)cyclohex-1-ene; 6,6-dimethyl-2-methylidenebicyclo[3.1.1]heptane; 7-methyl-3-methylideneocta-1,6-diene
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): Turpentine ; turpentine oil
Specific details on test material used for the study:
None.

Sampling and analysis

Analytical monitoring:
not required
Details on sampling:
Not applicable.

Test solutions

Vehicle:
no
Details on test solutions:
Not applicable.

Test organisms

Test organisms (species):
not specified
Details on test organisms:
None.

Study design

Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
32 d
Remarks on exposure duration:
None.
Post exposure observation period:
None.

Test conditions

Hardness:
Not applicable.
Test temperature:
Not applicable.
pH:
Not applicable.
Dissolved oxygen:
Not applicable.
Salinity:
Not applicable.
Conductivity:
Not applicable.
Nominal and measured concentrations:
Estimated value.
Details on test conditions:
None.
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
Duration:
32 d
Dose descriptor:
EL10
Effect conc.:
0.43 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
other: egg/sac fry, growth inhibition of juvenile fish, early life stage, full life cycle
Remarks on result:
other: result based on the typical composition
Details on results:
Not applicable.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
Not applicable.

Any other information on results incl. tables

Analytically Measured Aqueous Phase (AMAP) calculated at the predicted EL10.

constituents concentration in the WAF (mg.L-1)
Constituent 1 0.32
Constituent 2 0.07
Constituent 3 0.0051
Constituent 4 0.0034
Constituent 5 0.003
Constituent 6 0.0021
Constituent 7 0.0017
Constituent 8 0.00043

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The chronic toxicity to fish of the test item has been determined using the calculation method for mixtures based on WAF studies. The test item constituents which have been considered fall individually within the applicability domain of the model used to determine the chronic toxicity to fish (as the 32d-EC10). Therefore, the final result for the test item can be considered valid for use in risk assessment and classification and labelling.
The 32d-EL10 of the test item to fish was predicted as 0.43 mg/L.
Executive summary:

A calculation method prediction was performed to assess the chronic toxicity to fish of the test item, GUM TURPENTINE OIL using the WAF method. This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 210, "Fish, Early-life Stage Toxicity Test" (OECD, 2013). The criterion predicted was the EL10 (10% Effective Loading rate), a loading rate which is expected to cause an effect of 10% on growth within a period of 32 days. The chronic toxicity to fish was determined using a calculation method for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (Bauer et al., 2018). This method has previously been validated in an internal publication for acute exposure of non-polar narcosis compounds (Bicherel and Thomas, 2014). The algorithm is based on a QSAR model which has been validated to be compliant with the OECD recommandations for QSAR modeling (OECD, 2004, 2007). The QSAR model is based on validated data for a training set of 27 chemicals derived from 32-day test on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period. Further to this the effective loading rate of the WAF is determined by using a series of calculation steps using phase equilibrium thermodynamics and excluding the non-bioavailable fraction, this approach is based on validated data derived from 32-day EL10 tests on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period.

The result below is the chronic toxicity value anticipated during a 32-day EL10study on fish based on the WAF method. The 32-day EL10is calculated as follows:  

Composition

Time (d)

EL10(mg test item.L-1)

typical

32

0.43