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EC number: 292-429-7
CAS number: 90622-29-0
Short description of key information:
Regarding potential effects of
the registered substance on reproductive tissues, no test
article-related gross or microscopic findings were noted. The
microscopic findings observed were considered incidental, of the nature
commonly observed in this strain and age of rat, and/or were of similar
incidence and severity in control and treated animals and, therefore,
were considered unrelated to administration of Alkenes, C13-C14,
hydroformylation products, distn. residues. Thus the NOEL for effects on
reproductive tissues is considered to be 1000 mg/kg/day.
Based on the results of this study, 1000 mg/kg/day was considered to be the maternal and fetal no observed effect level (NOEL)
There were no premature deaths during the
Group/Dose Level (mg/kg/day)
Staining on fur
Scab(s) on skin
Maternal Necropsy Findings
Skin – Scab(s)
Skin – Staining on fur
Skin – Thin haircoat
Uterus – Fused placentae
Uterus – No visible signs of implantation or countable corpora lutea
Number of Females
At 1000 mg/kg/day, ploughing behaviour
(animal burrowing through bedding with its head) was noted in 5/24
animals and excess salivation was noted in one animal. These
observations were transient, being noted immediately post dose and no
longer being evident 1 hour after dosing, and were generally noted on
only one or two occasions in each individual between Days 15-19 of
gestation. Ploughing behaviour was also noted in one animal at 300
All other clinical observations were
considered to be incidental background findings commonly observed in
this species at Charles River, Edinburgh.
Group mean food consumption was similar in
control and treated groups throughout the study.
There were no macroscopic necropsy
findings in dams or foetuses which were considered to be related to
treatment with Alchisor H5. All findings were considered to be
incidental findings and those commonly observed in this species at
Charles River, Edinburgh.
Pregnancy Performance and Fetal Weights
Pregnancy performance and fetal weights
were similar in all groups. Slight intergroup variations were
considered to be incidental and too small to be attributed to
treatment with Alchisor H5.
Pregnancy Performance and Fetal Weights
Dose Group/Dose Level (mg/kg/day)
Number of animals mated
Number of non-pregnant animals
Number pregnant at Day 20 necropsy
Pregnancy Frequency as %
Total corpora lutea graviditatis
Total number of implants
Pre-implantation loss as %
Total live implants (%)
Total dead implants (%)
Total early embryonic deaths (%)
Total late embryonic deaths (%)
Total fetal deaths (%)
Mean corpora lutea graviditatis
14.8 ± 1.5
14.5 ± 1.8
15.0 ± 2.0
14.7 ± 2.0
14.2 ± 2.6
14.0 ± 1.2
14.6 ± 2.2
13.9 ± 2.6
Mean live implants
13.3 ± 3.0
13.4 ± 1.3
13.8 ± 2.6
12.9 ± 2.6
Mean dead implants
0.9 ± 1.6
0.5 ± 0.8
0.9 ± 1.1
1.0 ± 0.9
Mean early embryonic deaths
0.7 ± 1.1
0.8 ± 1.1
0.9 ± 0.9
Mean late embryonic deaths
0.3 ± 1.0
0.04 ± 0.2
0.1 ± 0.3
Mean fetal deaths
Total live male fetuses (%)
Total live female fetuses (%)
Live fetal sex ratio (male:female)
Mean total uterus weight (g)
82 ± 16
82 ± 7
85 ± 14
81 ± 14
Mean litter mean fetal weight (g) †
3.90 ± 0.24
3.89 ± 0.27
3.92 ± 0.17
3.88 ± 0.22
† - Statistically analysed, no statistical significance achieved (p < 0.001).
Non-pregnant animals excluded below the double line.
Fetal Abnormalities and Variants
The type and distribution of major and
minor fetal abnormalities and skeletal ossification parameters did not
indicate any association with treatment. Slight intergroup
differences were considered to be incidental and unrelated to
treatment with Alchisor H5.
Group Incidence of Major Fetal
Incidence of Fetuses (Litters)
Markedly increased subcutaneous spaces head and cervical regions
Lateral brain ventricles dilated
Scapula and radius bent, with humerus shortened and/or bent.
Right subclavian artery retro-oesophageal
Partially duplicated inferior vena cava
Sternebra fused. Bilateral rib(s) costal cartilages fused at point of attachment to sternum. Ribs and costal cartilages partially fused.
Sternum flattened, with sternebrae connected
Abdominal situs inversus
Number with major abnormality
Total number examined
of this study was to determine the potential toxicity ofAlkenes,
C11/C12, Hydroformylation Products, Distillation Residues (CAS/No.
90622-27-8)when the material was
administered during the period of organogenesis to pregnant rats.
the test item may be referred to as its alternative name “Alchisor H5”
where appropriate for the remainder of the report.
The study design was as follows:
Number of Animals
*The control item was 0.5% HPMC (Methocel E4M), 01% Tween 80 in Milli-Q water.
All animals were dosed over Days
6-19, inclusive, of gestation, where the day of detection of mating
was designated Day 0.
Animals were regularly monitored for
clinical signs of toxicity, body weights and food consumption
performance and were killed on Day 20 of gestation for examination of
pregnancies and embryo-fetal development.
Dosing of Alchisor H5 at dose levels
up to 1000 mg/kg/day was not associated with any treatment related
effects on body weight or food consumption, or any gross necropsy
findings in dams or foetuses. At 300 and 1000 mg/kg/day, clinical
observations of ploughing behaviour and excess salivation were
considered not to be adverse due to their transient nature and low
Pregnancy performance and fetal
weights were similar in control and treated groups, and the type and
distribution of major fetal abnormalities, minor visceral and skeletal
abnormalities and variants and skeletal ossification parameters did
not indicate an association with treatment with Alchisor H5.
Based on the results of this study,
1000 mg/kg/day was considered to be the maternal no observed adverse
effect level (NOAEL) and the fetal no observed effect level (NOEL).
The absence of reproductive or developmental
effects at the highest dose level tested supports the conclusion that
the registered substance is not classifiable as to reproductive and
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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