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EC number: 203-984-1 | CAS number: 112-55-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A study report was not available for this study, and some data were not reported in study summaries. However, OECD determined that this study was reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octane-1-thiol (CAS # 111-88-6)
- IUPAC Name:
- Octane-1-thiol (CAS # 111-88-6)
- Details on test material:
- Substance; octane-1-thiol (CAS No. 111-88-6)
Manufacturer; Kao Corporation (Japan)
Purity; 99.3 wt%
Impurity; C8 beta-gamma 0.6 area %, C10 0.1 area %
Lot No.; 1815
Test substance was stored at room temperature before use.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
Seven weeks old Sprague-Dawley (Crj:CD(SD)IGS, SPF) rats obtained from Charles River Japan, Inc. They were put in quarantine for 6 days before use, and their performance status was observed. Then they were put in pre-breeding before administration, and the clinical signs and estrous cycles were checked.
-Age at the start of administration: 9 weeks old
-Weight at the start of administration:
Male; 331-379 grams
Female; 202-254 grams
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- No data reported
- Details on mating procedure:
- No data reported
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Test solutions were analyzed and warranted to be stable for 9 days. No other data on analytical verification was reported.
- Duration of treatment / exposure:
- Male; 35 days,
Female; from 14 days before mating to day 4 of lactation - Frequency of treatment:
- Once daily
- Details on study schedule:
- Terminal killing (parental animals):
Male; day 36,
Female; day 5 of lactation
Offspring; 4 days after birth
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 50, 250 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Sperm parameters (parental animals):
- No data
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals on day 36
- Maternal animals: All surviving animals on day 5 post-partum
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [3, 4, 5, and 6] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals were sacrificed at 5 days of age.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [3, 4, 5, and 6] were prepared for microscopic examination and weighed, respectively. - Statistics:
- Five percent (significant level)
Multiple comparison test, multiple comparison test of Kruskal-Wallis and Dunnett type, and Fisher's exact test were performed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
No deaths were observed. Some toxicological changes were observed at forestomach in 50 and 250 mg/kg/day groups. And severe changes were observed at many organs in the 250 mg/kg/day group.
Reproductive and developmental toxicity
(1) Reproductive performance
-At 250 mg/kg/day group: Extension of mean estrous cycle was observed.
-At 10 and 50 mg/kg/day group: No abnormality was observed.
(2) Delivery and lactation
-At 250 mg/kg/day group: Extension of gestation length and low value of delivery index were observed.
-At 10 and 50 mg/kg/day group: No abnormality was observed.
(3) Morphology, body weight and necropsy findings of offspring
There were no toxicological significances related with test substance in any treatment group.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Reproductive/Developmental Toxicity
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive performance
- Dose descriptor:
- NOAEL
- Remarks:
- Reproductive/Developmental Toxicity
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Extension of mean estrous cycle and gestation length and low value of delivery index were observed for females in 250 mg/kg/day group.
- Dose descriptor:
- NOAEL
- Remarks:
- Maternal Toxicity
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Some toxicological changes were observed at forestomach in 50 and 250 mg/kg/day groups. And severe changes were observed at many organs in the 250 mg/kg/day group.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Remarks:
- Offspring
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1. Reproductive performance
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
No. of animals |
12 |
12 |
12 |
12 |
Mean estrous cycle |
3.98 |
4.00 |
4.08 |
4.36** |
No. of females with irregular estrous cycle |
0/12 |
0/12 |
0/12 |
0/12 |
Mating period/ No. of estrous |
0.0 |
0.0 |
0.0 |
0.1 |
Day of conceiving |
1.7 |
2.3 |
2.0 |
2.6 |
Copulation index (%) a |
91.7 |
100.0 |
100.0 |
100.0 |
Fertility index (%) b |
100.0 |
100.0 |
91.7 |
100.0 |
a: (No. of copulated females)/(No. of pairs)
b: (No. of pregnant females)/(No. of copulated females)
*: Significant difference from control, p<0.05
** Significant difference from control, p<0.01
Table 2. Delivery data
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
n |
11 |
12 |
11 |
12 |
Gestation length (days) |
22.2 |
22.7 |
22.5 |
22.8** |
No. of corpora lutea |
16.8 |
16.2 |
16.6 |
17.3 |
No. of implantation sites |
15.9 |
14.9 |
15.9 |
16.3 |
Total No. of offspring |
15.7 |
14.5 |
15.3 |
13.9 |
Implantation index (%) |
94.23 |
91.62 |
95.43 |
93.93 |
Delivery index (%) |
98.85 |
97.41 |
95.97 |
85.85** |
Gestation index (%) a) |
100.0 |
100.0 |
100.0 |
100.0 |
a: (No. of pregnant animals delivered live offspring)/(No.of pregnant animals)
*: Significant difference from control, p<0.05
**: Significant difference from control, p<0.01
Table 3. Absolute organ weight
-Female
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
No. of animals |
11 |
12 |
11 |
12 |
Terminal body weight (g) |
298.5 |
313.0 |
303.8 |
287.5 |
Thymus (mg) |
202.4 |
228.8 |
212.5 |
159.5 |
Liver (g) |
10.266 |
10.925 |
10.560 |
11.349* |
Spleen (g) |
0.603 |
.0700 |
0.669 |
0.902** |
Adrenal (mg) |
74.35 |
70.74 |
74.00 |
93.01** |
*:
Significant difference from control, p<0.05
**: Significant difference from control, p<0.01
Table 4. Relative organ weight
-Female
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
No. of animals |
11 |
12 |
11 |
12 |
Thymus (10E-3) |
67.05 |
72.46 |
68.68 |
54.82 |
Liver (g) |
3.436 |
3.491 |
3.481 |
3.945** |
Spleen (g) |
0.202 |
0.223 |
0.221 |
0.313** |
Kidney |
0.662 |
0.638 |
0.638 |
0.717** |
Adrenal (mg) |
24.93 |
22.64 |
24.40 |
32.48* |
*:
Significant difference from control, p<0.05
**: Significant difference from control, p<0.01
Table 5. Necropsy findings
-Female
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
No. of animals |
12 |
12 |
12 |
12 |
Spleen |
||||
Dark reddish |
0 |
0 |
0 |
3 |
Enlargement |
0 |
0 |
0 |
2 |
Stomach Thickening of wall, forestomach |
0 |
0 |
0 |
12 |
Table 6. Histological findings
-Female
Dose (mg/kg/day) |
0 |
10 |
50 |
250 |
No. of animals |
12 |
12 |
12 |
12 |
Stomach |
||||
Edema, forestomach |
0 |
0 |
1 |
7** |
Erosion, forestomach |
0 |
0 |
0 |
3 |
Hyperkeratosis |
0 |
0 |
1 |
10** |
Hyperkeratosis squamous, forestomach |
0 |
0 |
1 |
10** |
Inflammatory cell infiltration, forestomach |
0 |
0 |
1 |
6** |
Ulcer, forestomach |
0 |
0 |
1 |
0 |
Spleen |
||||
Congestion |
0 |
0 |
0 |
4* |
Extramedullary hematopoiesis, erythrocytic |
6 |
7 |
6 |
12** |
Hemosiderin deposition |
2 |
1 |
3 |
12** |
Thymus |
||||
Atrophy |
3 |
0 |
3 |
8* |
Liver |
||||
Hypertrophy, hepatocyte, centrilobular |
0 |
0 |
1 |
3 |
*:
Significant difference from control, p<0.05
**: Significant difference from control, p<0.01
Applicant's summary and conclusion
- Conclusions:
- In a reproduction/developmental toxicity study where groups of male and female rats exposed to octane-1-thiol, study results indicated the NOAEL for reproductive/developmental toxicity was 250 and 50 mg/kg bw/day for males and females respectively; the NOAEL for maternal toxicity was 10 mg/kg bw/day; and the NOAEL for the offspring was 250 mg/kg bw/day.
- Executive summary:
In a reproduction/developmental study (OECD 422), groups of male and female Sprague-Dawley rats (Crj: CD(SD) IGS, SPF; 12/sex/dose) were administered 0, 10, 50 or 250 mg/kg bw/day of octane-1-thiol (CAS Number 111-88-6) by gavage in olive oil daily for 35 days in males and from 14 days before mating to day 4 of lactation for females. The animals were sacrificed on the 36th day for the males and on the 5th day post-partum/after birth for the females and pups respectively.
No treatment-related mortality occurred during the study. There were no treatment-related effects at any dose on reproductive and developmental parameters for males. For females, there was an extension of the mean estrous cycle and gestation length as well as a low delivery index at 250 mg/kg bw/day. Necropsy revealed significant maternal toxicity effects to the stomach, spleen, and thymus in females at 50 and 250 mg/kg bw/day. Females also showed an absolute and relative increase in weight of the spleen, liver, adrenal, a relative weight increase in the kidney, and a decrease in absolute and relative weight in the thymus in 250 mg/kg bw. There were no treatment-related effects at any dose on offspring.
The NOAEL for reproductive/developmental toxicity was 250 and 50 mg/kg bw/day for males and females respectively. The NOAEL for maternal toxicity was 10 mg/kg bw/day. The NOAEL for the offspring was 250 mg/kg bw/day.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it followed sound scientific guidelines.
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