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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
not stated
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (draft guideline) with acceptable restrictions, on a related material.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
other: Draft OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Principles of method if other than guideline:
conducted according to Draft OECD 422 Combined repeat dose and reproductive/developmental toxicity screening test
GLP compliance:
yes (incl. QA statement)
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): 1-ocatadecanol
- Molecular formula (if other than submission substance): C18-H38-O
- Molecular weight (if other than submission substance): 270.497
- Smiles notation (if other than submission substance): C(CCCCCCCCC)CCCCCCCCO
- InChl (if other than submission substance): 1/C18H38O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19/h19H,2-18H2,1H3
- Structural formula attached as image file (if other than submission substance): see Fig 1
- Substance type: no data
- Physical state: no data
- Analytical purity: 99%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: L5751
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Details on test animals or test system and environmental conditions:
- Source: Moellegard Breeding Centre
- Age at study initiation: 8 (males) and 7 (females) weeks
- Weight at study initiation: not specified
- Fasting period before study: Not specified
- Housing: 2 rats/cage for acclimatization period then individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): fluorescent light was on from 8 pm to 8 am

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: feed
unchanged (no vehicle)
Details on exposure:
- Diet preparation involved first mixing the octadecanol with the barley component, the proportion of which varied for each dose level. The other components of the diet were then added.
- Rate of preparation of diet (frequency): not specified
- Mixing appropriate amounts with (Type of food): IT chow 101 diet
- Storage temperature of food: not specified
Analytical verification of doses or concentrations:
Details on mating procedure:
- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: up to 22 days
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no
- Proof of pregnancy: vaginal plug referred to as day 0 or, if the plug was recorded during the morning, day 1 of pregnancy
- Any other deviations from standard protocol: none
Duration of treatment / exposure:
Females up to 54 days, premating, mating and gestation until post natal day 5.
Males also treated.
Frequency of treatment:
continuous in diet
Duration of test:
From 14 days prior to mating then throughout mating and gestation until post natal day 5
Doses / concentrations
Doses / Concentrations:
0, 1500, 7500 or 30,000 ppm (ca 0, 100, 500, 2000 mg/kg/bw/day)
nominal in diet
No. of animals per sex per dose:
Control animals:
yes, plain diet
Details on study design:
- Dose selection rationale: Doses chosen from the results of a preliminary test.
- Rationale for animal assignment (if not random): Randomized into 4 groups with the same mean body weight


Maternal examinations:

- Time schedule: not specified

- Time schedule for examinations: During the experiment the males were weighed once/week. The females were weighed during the premating period and during pregnancy once/week. Pup litter weight was determined on days 1 and 4 after birth.

- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes

- Sacrifice on postnatal day 5
- Organs examined: liver, kidney, adrenals, brain, heart, spleen, ovaries, thymus and other organs with observed pathological changes.

OTHER: Total gross pathological examinations were performed on each animal at necropsy and organ weights determined for the liver, kidneys and thymus.
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data
- Other: number of resorptions was examined but it is not specified whether these were early or late.
Fetal examinations:
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: No
- Head examinations: Yes: all per litter
Statistical analysis made on all data using the SAS-stat program. All statistically significant findings were further evaluated by means of Dunnett¿s t-test to assess possible inter-group differences.
Pregnancy rate
Historical control data:

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
- Body weight: No treatment related effects.
- Food/water consumption: No treatment related effects.
- Description, severity, time of onset and duration of clinical signs: None reported.
- Pregnancy rate: There was no statistically significant difference in pregnancy rates (confirmed using a Chi-squared test) although they were reduced in treated groups C 92%, 100 & 500 mg/kg 75%, 2000 mg/kg/day 67% these were within the normal historical control range according to the investigators (actual historical control data not presented).
- Fertility index: Not reported
- Precoital interval: Not reported
- Duration of gestation: Comparable in treated and control dams.
- Gestation index: Not reported
- Changes in lactation: Not reported
- Changes in estrus cycles: Not reported
- Mortality: None
- Number of implantations: No significant differences in the numbers of implantations between treated and control groups. (Mean 13 in controls and low dose, 15 in mid and high dose groups). Resorptions mean for controls and low dose 0, for mid and high dose 1).
- Number of corpora lutea: No significant differences between treated and control groups (mean controls 13, low and mid dose 14, high dose 15).
- Ovarian primordial follicle counts: Not reported

Effect levels (maternal animals)

Dose descriptor:
Effect level:
2 000 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
- Litter size and weights: No effect of treatment (mean litter size 11.73, 10.0, 13.6 and 13.38 for controls, low, mid and high dose respectively). Litter
weights day 1 mean 69, 61, 75 and 75 g; Day 4 mean 96, 84, 101 and 101 g for controls, low, mid and high dose respectively)
- Sex and sex ratios: No treatment related effects.
- Post natal survival until day 5: Similar in treated and control groups.
- Foetal anomalies: There were no treatment related changes in the incidence of external or visceral malformations visible on macroscopic examination.

Effect levels (fetuses)

Dose descriptor:
Effect level:
2 000 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

In a reliable study, development was assessed as part of a combined repeat dose and reproductive/developmental toxicity study, conducted according to draft OECD guideline 422. The NOAEL for maternal and foetotoxicity in rats was 2000 mg/kg bw/day (highest dose level). There was no evidence of teratogenicity from the limited examination of the pups that was carried out.