Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-001-8 | CAS number: 50-00-0
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study is comparable with OECD guideline 417 with acceptable restrictions (no data about toxic effects; no data are available on remaining radioactivity in carcass or total recovered amount resulting in limitation of the validity concerning absortion rate). Suitable for comparison of selected parameters with other species (see other study records of Jeffcoat et al.1983).
Data source
Reference
- Reference Type:
- publication
- Title:
- Disposition of 14C-formaldehyde after topical exposure to rats, guinea pigs, and monkeys
- Author:
- Jeffcoat AR, Chasalow F, Feldman D, Marr H
- Year:
- 1 983
- Bibliographic source:
- Gibson JE (1983) Formaldehyde toxicity, Hemisphere Publishing Corporation, Washington DC: 38-50
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 417
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- CH2O
- IUPAC Name:
- formaldehyde
- Details on test material:
- - Name of test material (as cited in study report): formaldehyde
Constituent 1
- Specific details on test material used for the study:
- No further details
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- monkey
- Strain:
- other: cynomolgus
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- - Source: Hazleton Primates, Vineland, NJ
monkeys: no data about sex (n=3).
Housing conditions: acclimatization period 1 month
no further data
Administration / exposure
- Type of coverage:
- other: presumably non-occlusive
- Vehicle:
- water
- Duration of exposure:
- 72 h
- Doses:
- 2 mg 14-formaldehyde in 200 µL solution (590-730 µCu)
- No. of animals per group:
- 3 animals per group
- Control animals:
- no
- Details on study design:
- Monkeys placed in a restraining chair with Plexiglass hood. 200 µL containing 2 mg test substance (590-730 µCi) applied to 18 cm² shaved area.
Blood samples collected 1, 2, 3, 4, 7, 24 h after dosing. Urine and faeces collected at daily intervals for 3 days. Traps for air exiting each chamber (traps for 14C-CO2). Scintillation counting.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- The skin of monkeys seems to be less permeable to aqueous formaldehyde than that of rodents (see other study records of the authors). Only 0.44% was excreted via urine and faeces. 0.37% was accounted for as 14CO2 in the air traps and 9.5% of the applied radioactivity was found at the site of application. No data are available on remaining carcass or total recovered amount.
- Total recovery:
- no data
Percutaneous absorption
- Remarks on result:
- other: no estimation of absorption rate possible
Any other information on results incl. tables
Table on mean values in % of applied dose for the distribution of 14C during the first 72 h after dermal application |
||||
Species |
Dose in mg |
Distribution of radioactivity |
Mean value ± SE |
Number of animals per group |
Monkey |
2 |
Air traps |
0.37+-0.17 |
Mean of 3 animals (sex not given) |
Presumably not occluded after application; aqueous solution; #: average of % dose in total blood volume over 1-24 h |
||||
Applicant's summary and conclusion
- Conclusions:
- The skin of monkeys seems to be less permeable than that of rats ot guinea pigs but results are of limited validity (carcass not measured).
- Executive summary:
The study is comparable with OECD guideline 417 with acceptable restrictions (no data about toxic effects; no data are available on remaining radioactivity in carcass or total recovered amount resulting in limitation of the validity concerning absortion rate). Suitable for comparison of selected parameters with other species (see other study records of Jeffcoat et al.1983).
Each of 3 monkeys received dermal 2 mg 14-formaldehyde in 200 µL solution.The skin of monkeys seems to be less permeable to aqueous formaldehyde than that of rodents (see other study records of the authors). Only 0.44% of applied radioactivity was excreted via urine and faeces; 0.37% was accounted for as 14CO2 in the air traps and 9.5% of the applied radioactivity was found at the site of application. No data are available on remaining carcass or total recovered amount.
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.
