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EC number: 925-653-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Aquatic toxicity
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- Long-term toxicity to aquatic invertebrates
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- Additional toxicological data
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Developmental toxicity / teratogenicity
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Sept. 1978 - 6 Oct. 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 11 Sept. 1978 - 6 Oct. 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Reason / purpose for cross-reference:
- read-across source
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There was no mortality in either of the dosage groups. Pregnancy rates were comparable between the exposure groups and negative controls. Weight gain was significantly higher in the exposure groups post-dosing. There were no significant clinical observations in either exposure group. The mean number of corpora lutea was significantly decreased in the 300 ppm group. Since ovulation occurred prior to exposure, this was not considered to be treatment related. The mean number of implantations was comparable between exposure groups and negative controls. The implantation efficiency values were actually significantly higher in exposure groups as compared to negative controls. The mean number of live fetuses, resorption sites, and number of dams with more than one resorption site were comparable between exposures and negative controls. The gross postmortem examination of dams showed no treatment related effects. - Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 300 ppm
- Basis for effect level:
- other: Systemic toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The body weights of fetal males in the 100 ppm group were significantly higher than negative controls. There were some statistically significant differences in mean crown-rump distance between both dosage levels and negative controls, these differences were slight and the effect inconsistant between dosages and sex. These differences were therefore not considered to be indicative of a treatment related effect. Mean numbers of male and female fetuses, and sex ratios were similar between exposure groups and negative controls. Ossification variations were similar in exposure groups and negative controls, as was the incidence of litters with fetuses containing ossification variations. No malformations externally or in the soft tissues were noted in the fetuses except in the positive controls. Though skeletal defects were noted in the exposure group, the types of malformations are common in rat fetus and not considered to be treatment related. - Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 300 ppm
- Based on:
- test mat.
- Basis for effect level:
- other: Developmental Toxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- The NOAEC for developmental toxicity in rats is >=300 ppm (1575 mg/m3) via inhalation. The test substance is also non-teratogenic.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) based on analogue read across.
This study determined the developmental toxicity of MRD-78 -25 in rats exposed via inhalation. Groups of 20 pregnant female rats were exposed 6 hrs/day during days 6 -15 of gestation. Test concentrations of 100 or 300 ppm test substance. In addition to a negative control group, there was also a positive control group that was exposed to acetylsalicylic acid on days 6 -15 of gestation. Dams were observed for toxicological signs and pharmacological effects. On day 21 of gestation, the animals were sacrificed, and examined for corpora lutea and uterine implantation parameters. Fetuses were examined for fetal size, sex ratio, and external, soft-tissue, and skeletal malformations. No adverse effects due to exposure to the test substance were seen in either dams or fetuses. No treatment related malformation effects were noted in the fetuses. The developmental NOAEC for rats by inhalation is >=300 ppm. The test substance is also not teratogenic.
Results - Dams
Endpoint |
Negative Control |
400 mg/kg ASA |
100 ppm |
300 ppm |
Pregnancy Rate (%) |
100.0 |
95.0 |
100.0 |
90.0 |
Mortality Rate (%) |
0.0 |
10.0 |
0.0 |
0.0 |
Mean Body Weight Gain (g) Dams - Days 15-21 |
84 |
32 |
108 |
103 |
Mean Corpora Lutea |
15.2 |
14.5 |
15.5 |
13.8 |
Mean No. Implantations |
13.0 |
13.2 |
13.8 |
13.2 |
Implantation Efficiency (%) |
85.8 |
91.1 |
88.7 |
95.6 |
Mean No. Live Fetuses |
12.5 |
7.4 |
12.9 |
12.6 |
Mean No. Dead Fetuses |
0.0 |
0.0 |
0.0 |
0.0 |
Mean No. Resorptions |
0.6 |
5.8 |
0.9 |
0.7 |
Dams with more than one Resorption (%) |
10.0 |
58.8 |
25.0 |
11.1 |
Results – Fetuses
Endpoint |
Negative Control |
400 mg/kg ASA |
100 ppm |
300 ppm |
Male Mean Fetal Weight (g) |
5.57 |
3.88 |
5.82 |
5.62 |
Female Mean Fetal Weight (g) |
5.29 |
3.62 |
5.44 |
5.33 |
Male Mean Crown-Rump Distance (cm) |
4.3 |
3.7 |
4.4 |
4.2 |
Female Mean Crown-Rump Distance (cm) |
4.2 |
3.6 |
4.2 |
4.1 |
Sex Ratio (%) |
91.5 |
98.4 |
88.3 |
105.5 |
Ossification Variations (%) |
70.7 |
100.0 |
79.4 |
79.3 |
Litters with Ossification Variations (%) |
100.0 |
100.0 |
95.0 |
100.0 |
Soft Tissue Malformations (%) |
2.4 |
26.8 |
1.1 |
3.9 |
Litters with Soft Tissue Malformations (%) |
10.0 |
54.5 |
5.0 |
16.7 |
Gross Evisceration Malformations (%) |
5.4 |
3.6 |
1.8 |
4.0 |
Litters with Gross Evisceration Malformations |
25.0 |
8.3 |
10.0 |
16.7 |
Skeletal Malformations (%) |
0.0 |
21.4 |
2.9 |
1.3 |
Litters with Skeletal Malformations |
0.0 |
66.7 |
15.0 |
11.1 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Reproduction Studies for Safety and Evaluation of Drugs for Human Use, Segment II (Teratology Study)
- GLP compliance:
- no
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: 7 weeks
- Fasting period before study: Animals were not given food during exposure.
- Housing: Individually, except during mating, in stainless steel cages, animals identified by ear tags
- Diet (e.g. ad libitum): Purina Lab Chow, ad libitum
- Water (e.g. ad libitum): Elizabethtown Water Company, ad libitum
- Acclimation period: Aug. 17, 1978-Sept. 4, 1978
ENVIRONMENTAL CONDITIONS
- Temperature (°C): monitored twice daily, room temperature
- Humidity (%): dry air
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: days 6-15 of gestation From: 11-27 Sept. 1978 To: 20 Sept. - 6 Oct. 1978
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: one cubic meter exposure chamber
- Temperature, humidity, pressure in air chamber: room temperature, dry air - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: Overnight and removed in morning to check for pregnancy, this was repeated until females were pregnant
- Proof of pregnancy: vaginal plug and sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 6 hrs/day
- Frequency of treatment:
- days 6-15 of gestation
- Duration of test:
- days 6-15 of gestation
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations: mortality, toxicological signs, pharmacological effects
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 6-15, 21 of gestation
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #: 21
- Organs examined: uterus, ovaries - Ovaries and uterine content:
- The ovaries and uterine content were examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: number of live fetuses, number of dead fetuses - Fetal examinations:
- - External examinations: Yes: all per litter examined for sex, crown-rump distance, weighed, and malformations
- Soft tissue examinations: Yes: 2/3 per litter examined for gross dissection and examination of viscera, internal sex determination, ureter, kidneys, and heart
- Skeletal examinations: Yes: 2/3 per litter examined for skeletal malformations, and ossification
- Head examinations: Yes: 1/3 per litter examined for neural defects - Statistics:
- Analysis was done using the chi-square method, or the F-test and Student's t-test. When the variance differed significantly, the Student's t-test was modified suing Chochran's approximation. The mean number of live fetuses, resorptions, implantations, and corpora lutea were analyzed using the one-tailed t-test.
- Indices:
- implantation efficiency,
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There was no mortality in either of the dosage groups. Pregnancy rates were comparable between the exposure groups and negative controls. Weight gain was significantly higher in the exposure groups post-dosing. There were no significant clinical observations in either exposure group. The mean number of corpora lutea was significantly decreased in the 300 ppm group. Since ovulation occurred prior to exposure, this was not considered to be treatment related. The mean number of implantations was comparable between exposure groups and negative controls. The implantation efficiency values were actually significantly higher in exposure groups as compared to negative controls. The mean number of live fetuses, resorption sites, and number of dams with more than one resorption site were comparable between exposures and negative controls. The gross postmortem examination of dams showed no treatment related effects.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 300 ppm
- Basis for effect level:
- other: Systemic toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The body weights of fetal males in the 100 ppm group were significantly higher than negative controls. There were some statistically significant differences in mean crown-rump distance between both dosage levels and negative controls, these differences were slight and the effect inconsistant between dosages and sex. These differences were therefore not considered to be indicative of a treatment related effect. Mean numbers of male and female fetuses, and sex ratios were similar between exposure groups and negative controls. Ossification variations were similar in exposure groups and negative controls, as was the incidence of litters with fetuses containing ossification variations. No malformations externally or in the soft tissues were noted in the fetuses except in the positive controls. Though skeletal defects were noted in the exposure group, the types of malformations are common in rat fetus and not considered to be treatment related.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- >= 300 ppm
- Based on:
- test mat.
- Basis for effect level:
- other: Developmental Toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Results - Dams
Endpoint |
Negative Control |
400 mg/kg ASA |
100 ppm |
300 ppm |
Pregnancy Rate (%) |
100.0 |
95.0 |
100.0 |
90.0 |
Mortality Rate (%) |
0.0 |
10.0 |
0.0 |
0.0 |
Mean Body Weight Gain (g) Dams - Days 15-21 |
84 |
32 |
108 |
103 |
Mean Corpora Lutea |
15.2 |
14.5 |
15.5 |
13.8 |
Mean No. Implantations |
13.0 |
13.2 |
13.8 |
13.2 |
Implantation Efficiency (%) |
85.8 |
91.1 |
88.7 |
95.6 |
Mean No. Live Fetuses |
12.5 |
7.4 |
12.9 |
12.6 |
Mean No. Dead Fetuses |
0.0 |
0.0 |
0.0 |
0.0 |
Mean No. Resorptions |
0.6 |
5.8 |
0.9 |
0.7 |
Dams with more than one Resorption (%) |
10.0 |
58.8 |
25.0 |
11.1 |
Results – Fetuses
Endpoint |
Negative Control |
400 mg/kg ASA |
100 ppm |
300 ppm |
Male Mean Fetal Weight (g) |
5.57 |
3.88 |
5.82 |
5.62 |
Female Mean Fetal Weight (g) |
5.29 |
3.62 |
5.44 |
5.33 |
Male Mean Crown-Rump Distance (cm) |
4.3 |
3.7 |
4.4 |
4.2 |
Female Mean Crown-Rump Distance (cm) |
4.2 |
3.6 |
4.2 |
4.1 |
Sex Ratio (%) |
91.5 |
98.4 |
88.3 |
105.5 |
Ossification Variations (%) |
70.7 |
100.0 |
79.4 |
79.3 |
Litters with Ossification Variations (%) |
100.0 |
100.0 |
95.0 |
100.0 |
Soft Tissue Malformations (%) |
2.4 |
26.8 |
1.1 |
3.9 |
Litters with Soft Tissue Malformations (%) |
10.0 |
54.5 |
5.0 |
16.7 |
Gross Evisceration Malformations (%) |
5.4 |
3.6 |
1.8 |
4.0 |
Litters with Gross Evisceration Malformations |
25.0 |
8.3 |
10.0 |
16.7 |
Skeletal Malformations (%) |
0.0 |
21.4 |
2.9 |
1.3 |
Litters with Skeletal Malformations |
0.0 |
66.7 |
15.0 |
11.1 |
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for developmental toxicity in rats is >=300 ppm (1575 mg/m3) via inhalation. The test substance is also non-teratogenic.
- Executive summary:
This study determined the developmental toxicity of MRD-78 -25 in rats exposed via inhalation. Groups of 20 pregnant female rats were exposed 6 hrs/day during days 6 -15 of gestation. Test concentrations of 100 or 300 ppm test substance. In addition to a negative control group, there was also a positive control group that was exposed to acetylsalicylic acid on days 6 -15 of gestation. Dams were observed for toxicological signs and pharmacological effects. On day 21 of gestation, the animals were sacrificed, and examined for corpora lutea and uterine implantation parameters. Fetuses were examined for fetal size, sex ratio, and external, soft-tissue, and skeletal malformations. No adverse effects due to exposure to the test substance were seen in either dams or fetuses. No treatment related malformation effects were noted in the fetuses. The developmental NOAEC for rats by inhalation is >=300 ppm. The test substance is also not teratogenic.
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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