Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientific justification for addressing the endpoint using data from an analogue substance.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
A review of available data on structural analogues of the registered substance, the results of which are read-across to draw conclusions on the developmental toxicity/teratogenicity potential of the registered substance.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Oleic acid, monoester with glycerol
EC Number:
247-038-6
EC Name:
Oleic acid, monoester with glycerol
Cas Number:
25496-72-4
IUPAC Name:
2-hydroxy-1-(hydroxymethyl)ethyl octadec-9-enoate
Constituent 2
Chemical structure
Reference substance name:
Glycerol
EC Number:
200-289-5
EC Name:
Glycerol
Cas Number:
56-81-5
Molecular formula:
C3H8O3
IUPAC Name:
glycerol
Constituent 3
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Constituent 4
Chemical structure
Reference substance name:
Boric acid
EC Number:
233-139-2
EC Name:
Boric acid
Cas Number:
10043-35-3
Molecular formula:
H3BO3
IUPAC Name:
Boric acid
Constituent 5
Reference substance name:
2133-139-2
IUPAC Name:
2133-139-2
Constituent 6
Reference substance name:
Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
EC Number:
293-187-5
EC Name:
Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
Cas Number:
91052-28-7
IUPAC Name:
91052-28-7
Test material form:
not specified
Details on test material:
CAS 25496-72-4/EC 247-038-6
- Name of test material (as cited in study report): glycerol monooleate
- Molecular formula (if other than submission substance): C21H40O4
- Molecular weight (if other than submission substance): 356.55
- Smiles notation (if other than submission substance): C(=O)(CCCCCCCC=CCCCCCCCC)OC(CO)CO
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: Organic

CAS 10043-35-3/EC 233-139-2
- Name of test material (as cited in study report): boric acid
- Molecular formula (if other than submission substance): H3O3B
- Molecular weight (if other than submission substance): 61.83
- Smiles notation (if other than submission substance): B(O)(O)O
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Inorganic

CAS 56-81-5/EC 200-289-5
- Name of test material (as cited in study report): glycerol
- Molecular formula (if other than submission substance): C3H8O3
- Molecular weight (if other than submission substance): 92.10
- Smiles notation (if other than submission substance): C(O)(CO)CO
- Structural formula attached as image file (if other than submission substance): see Fig. 3
- Substance type: Organic

CAS 112-80-1/EC 204-007-1
- Name of test material (as cited in study report): (9Z)-octadecenoic acid
- Molecular formula (if other than submission substance): C18H34O2
- Molecular weight (if other than submission substance): 282.47
- Smiles notation (if other than submission substance): C(=O)(O)CCCCCCCC=CCCCCCCCC
- Structural formula attached as image file (if other than submission substance): see Fig. 4
- Substance type: Organic

CAS 91052-28-7/EC 293-187-5
- Name of test material (as cited in study report): glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
- Substance type: Organic

Test animals

Species:
other: data is available for rat, mouse, and rabbit for the read across substances

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 other: mL/kg
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Dose descriptor:
NOEL
Effect level:
>= 1 180 - <= 1 310 other: mg/kg/day
Based on:
test mat.
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
9.6 other: mg boron/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Read-across to support the registration of 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol ester with boric acid using hydrolytic and metabolic breakdown products is considered to be acceptable. None of the data on the hydrolytic and metabolic breakdown products showed these substances to be toxic to development and so 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol ester with boric acid is also considered not to be toxic to development.