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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-180-5 | CAS number: 79-14-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycollic acid
- EC Number:
- 201-180-5
- EC Name:
- Glycollic acid
- Cas Number:
- 79-14-1
- Molecular formula:
- C2H4O3
- IUPAC Name:
- 2-hydroxyacetic acid
- Details on test material:
- Glycolic acid > 99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Hare Marland, Hewitt, New Jersey.
- Weight at study initiation: 2316-2620 grams.
- Housing: Received in suspended, stainless steel, wire-mesh cages. Then placed in 8"x18" stock fitted with rubber sheeting.
- Diet: Approximately 125 grams offered per day of Purina Certified High Fiber Rabbit Chow #5325.
- Water: Ad libitum.
- Acclimation period: Approximately 2 weeks.
-Age: Young.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2.
- Humidity (%): 50 +/- 10.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g.
- Concentration: 99% Glycolic Acid. - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- Observations noted after each exposure time and for up to 14 days after treatment
- Number of animals:
- 6 Females.
- Details on study design:
- TEST SITE
- Area of exposure: Back (from scapular to lumbar.)
- % coverage: not specified
- Type of wrap if used: 2-inch gauze held in place with non-irritating tape and covered with rubber sheeting during the
exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with Ivory soap after evaluations
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis: 3 minutes
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1 - 6
- Remarks:
- No edema observed at 3 minutes in any animal.
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: time basis 3 minutes
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 1 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- other: time basis 4 h
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- The test substance produced slight to mild erythema, but no edema in the treated rabbits following the 3-minute exposure period.
Necrosis was observed in 3 test sites after 1-hour exposure period. Mild to severe erythema and no to mild edema were also observed.
Necrosis was also observed in 4 test sites that were designated for the 4-hour exposure period but evaluated after a 1-hour exposure period. Mild to moderate erythema and no or moderate edema were observed in these test sites.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of this study, glycolic acid was a skin corrosive agent when applied to the shaved, intact skin of rabbits.
- Executive summary:
99% glycolic acid was evaluated in six female rabbits. The material was placed on two test sites of each rabbit for three minutes or one hour. The test material produced slight or mild erythema, but no edema in the treated rabbits after the three-minute exposure. Necrosis was seen in three test sites after a one-hour exposure; mild to severe erythema and no to mild edema were also seen. Necrosis was also seen in four test sites that were designated for a four-hour exposure but evaluated after an one hour exposure; mild to moderate erythema and no to moderate edema were seen in these test sites. Thus 99% glycolic acid is a skin corrosive when applied to shaved, intact rabbit skin. Under the conditions of this test, Glycolic acid is considered to be corrosive to the skin.
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.
