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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-915-7 | CAS number: 75-91-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR 163.81-4
- Deviations:
- yes
- Remarks:
- The test material was also instilled in the eye of 3 additional animals and subsequently washed out 30 seconds after treatment with warm water.
- Principles of method if other than guideline:
- The test material was also instilled in the eye of 3 additional animals and subsequently washed out 30 seconds after treatment with warm water.
- GLP compliance:
- yes
Test material
- Reference substance name:
- tert-butyl hydroperoxide
- EC Number:
- 200-915-7
- EC Name:
- tert-butyl hydroperoxide
- Cas Number:
- 75-91-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-methylpropane-2-peroxol
- Details on test material:
- Aqueous solution containing ca. 70 wt% TBHP
Tertiary-Butyl Hydroperoxide content 70%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Marland farms, Hewitt, NJ
- Housing: Indiviual, suspended cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye
- Concentration (if solution): undiluted test material (i.e. 70% TBHP) - Duration of treatment / exposure:
- First group: 7 days (if positive readings were observed within 7 days, exposure time is 21 days)
Second group: 30 seconds - Observation period (in vivo):
- First group: 7 days (21 days if positive readings observed)
Second group: 7 days (21 days if positive readings observed) - Number of animals or in vitro replicates:
- First group: 6
Second group: 3
Total: 9 (4 males 5 females) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with 125 mL of lukewarm water (second group only)
- Time after start of exposure: 30 seconds (second group only)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 19 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 19 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 19 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Unwashed eye group
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- Area
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 3.72
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.77
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.82
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 1.05
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Unwashed eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: Average over 21 days
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- other: see other effects section
- Remarks on result:
- other: Washed eye
- Irritant / corrosive response data:
- See table 1 and 2 for detailed results.
- Other effects:
- First group: All 6 rabbits had mild erythema, mild to marked chemosis and discharge. These changes disappeared in 2 rabbits by day 16 and 3 rabbits by day 21. Rabbit no. 5 was found dead on day 17 of undetermined cause. iritis and corneal opacity was seen in all rabbits. Keratitis, corneal ulcers and keratoconus was also seen. Iritis had cleared in 2 rabbits by day 13 and either persisted in the remainder or the iris could not be visualised due to the corneal opacities that persisted in all six rabbits through 21 days.
Second group: Mild to moderate changes were seen in all six rabbits. These changes cleared in 1 rabbit at 7 days and 1 rabbit by day 21. Iritis and corneal opacities were seen in all three rabbits. In addition, keratoconus, corneal erosions, keratitis and anterior synechia were seen. Iritis had cleared in 1 rabbit by day 7 and persisted through 21 days in the remaining 2. Corneal opacities persisted through 21 days in all three rabbits.
Any other information on results incl. tables
Table 1 Irritation scores for the unwashed eye group.
| Animal | |||||||||
| Time | Effect | 1F | 2F | 3F | 4M | 5M | 6M | Mean | |
| 24 hours | Cornea | Opacity | 2 | 2 | 2 | 2 | 2 | 2 | 2.0 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 1 | 2 | 1 | 2 | 3 | 4 | 2.2 | ||
| Discharge | 2 | 2 | 2 | 2 | 2 | 2 | 2.0 | ||
| 48 hours | Cornea | Opacity | 2 | 2 | 2 | 2 | 2 | 2 | 2.0 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 1 | 1 | 1 | 2 | 3 | 4 | 2.0 | ||
| Discharge | 1 | 2 | 1 | 1 | 2 | 2 | 1.5 | ||
| 72 hours | Cornea | Opacity | 3 | 3 | 3 | 2 | 2 | 1 | 2.3 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | * | * | * | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 1 | 1 | 1 | 2 | 2 | 2 | 1.5 | ||
| Discharge | 1 | 2 | 1 | 1 | 2 | 2 | 1.5 | ||
| 96 hours | Cornea | Opacity | 3 | 3 | 3 | 2 | 2 | 1 | 2.3 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | * | * | * | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 0 | 1 | 1 | 1 | 1 | 2 | 1.0 | ||
| Discharge | 1 | 2 | 1 | 1 | 1 | 2 | 1.3 | ||
| 7 days | Cornea | Opacity | 2 | 3 | 3 | 3 | 4 | 2 | 2.8 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 1 | * | * | * | * | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 0 | 0 | 0 | 1 | 0 | 1 | 0.3 | ||
| Discharge | 1 | 1 | 1 | 2 | 1 | 1 | 1.2 | ||
| 10 days | Cornea | Opacity | 2 | 3 | 2 | 3 | 3 | 2 | 2.5 |
| Area | 4 | 4 | 4 | 4 | 4 | 2 | 3.7 | ||
| Iris | Value | 1 | * | 1 | * | * | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 0 | 0 | 0 | 1 | 1 | 1 | 0.5 | ||
| Discharge | 1 | 1 | 0 | 2 | 1 | 1 | 1.0 | ||
| 13 days | Cornea | Opacity | 2 | 2 | 2 | 3 | 3 | 4 | 2.7 |
| Area | 4 | 4 | 4 | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 0 | 1 | 0 | 1 | * | * | 0.5 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | |
| Chemosis | 0 | 0 | 0 | 1 | 1 | 1 | 0.5 | ||
| Discharge | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | ||
| 16 days | Cornea | Opacity | 2 | 2 | 2 | 3 | d | 4 | 2.2 |
| Area | 4 | 4 | 4 | 4 | d | 4 | 3.3 | ||
| Iris | Value | 0 | 1 | 0 | 1 | d | * | 0.4 | |
| Conjunctivae | Redness | 0 | 1 | 0 | 1 | d | 1 | 0.5 | |
| Chemosis | 0 | 0 | 0 | 1 | d | 0 | 0.2 | ||
| Discharge | 0 | 1 | 0 | 1 | d | 1 | 0.5 | ||
| 19 days | Cornea | Opacity | 2 | 2 | 2 | 3 | d | 4 | 2.2 |
| Area | 4 | 4 | 4 | 4 | d | 4 | 3.3 | ||
| Iris | Value | 0 | 1 | 0 | 1 | d | * | 0.4 | |
| Conjunctivae | Redness | 0 | 0 | 1 | 1 | d | 1 | 0.5 | |
| Chemosis | 0 | 0 | 0 | 0 | d | 0 | 0.0 | ||
| Discharge | 0 | 1 | 0 | 1 | d | 1 | 0.5 | ||
| 21 days | Cornea | Opacity | 1 | 2 | 2 | 3 | d | 4 | 2.0 |
| Area | 1 | 4 | 4 | 4 | d | 4 | 2.8 | ||
| Iris | Value | 0 | 1 | 0 | 1 | d | * | 0.4 | |
| Conjunctivae | Redness | 0 | 0 | 0 | 0 | d | 0 | 0.0 | |
| Chemosis | 0 | 0 | 0 | 0 | d | 0 | 0.0 | ||
| Discharge | 0 | 0 | 0 | 0 | d | 0 | 0.0 | ||
* Cannot be visualised
d = dead
Table 2 Irritation scores for washed eyes group
| Animal | ||||||
| Time | Effect | 7F | 8F | 9M | Mean | |
| 24 hours | Cornea | Opacity | 1 | 2 | 2 | 1.7 |
| Area | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1.0 | |
| Chemosis | 2 | 2 | 2 | 2.0 | ||
| Discharge | 2 | 2 | 2 | 2.0 | ||
| 48 hours | Cornea | Opacity | 3 | 3 | 2 | 2.7 |
| Area | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | * | * | 1 | 0.3 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1.0 | |
| Chemosis | 3 | 2 | 2 | 2.3 | ||
| Discharge | 1 | 2 | 2 | 1.7 | ||
| 72 hours | Cornea | Opacity | 3 | 3 | 2 | 2.7 |
| Area | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | * | * | 1 | 0.3 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1.0 | |
| Chemosis | 2 | 2 | 1 | 1.7 | ||
| Discharge | 2 | 2 | 1 | 1.7 | ||
| 96 hours | Cornea | Opacity | 3 | 3 | 2 | 2.7 |
| Area | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | * | * | 1 | 0.3 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1.0 | |
| Chemosis | 2 | 1 | 1 | 1.3 | ||
| Discharge | 2 | 1 | 1 | 1.3 | ||
| 7 days | Cornea | Opacity | 2 | 2 | 2 | 2.0 |
| Area | 4 | 4 | 4 | 4.0 | ||
| Iris | Value | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 0 | 0 | 0.3 | |
| Chemosis | 1 | 0 | 0 | 0.3 | ||
| Discharge | 1 | 0 | 1 | 0.7 | ||
| 10 days | Cornea | Opacity | 2 | 1 | 3 | 2.0 |
| Area | 4 | 4 | 3 | 3.7 | ||
| Iris | Value | 1 | 1 | 1 | 1.0 | |
| Conjunctivae | Redness | 1 | 1 | 1 | 1.0 | |
| Chemosis | 1 | 0 | 0 | 0.3 | ||
| Discharge | 1 | 1 | 1 | 1.0 | ||
| 13 days | Cornea | Opacity | 2 | 1 | 3 | 2.0 |
| Area | 4 | 2 | 4 | 3.3 | ||
| Iris | Value | 1 | 0 | * | 0.3 | |
| Conjunctivae | Redness | 1 | 0 | 1 | 0.7 | |
| Chemosis | 1 | 0 | 0 | 0.3 | ||
| Discharge | 1 | 1 | 1 | 1.0 | ||
| 16 days | Cornea | Opacity | 2 | 1 | 3 | 2.0 |
| Area | 4 | 2 | 4 | 3.3 | ||
| Iris | Value | 1 | 0 | * | 0.3 | |
| Conjunctivae | Redness | 1 | 0 | 0 | 0.3 | |
| Chemosis | 1 | 0 | 0 | 0.3 | ||
| Discharge | 1 | 0 | 0 | 0.3 | ||
| 19 days | Cornea | Opacity | 2 | 1 | 3 | 2.0 |
| Area | 4 | 2 | 4 | 3.3 | ||
| Iris | Value | 1 | 0 | * | 0.3 | |
| Conjunctivae | Redness | 1 | 0 | 0 | 0.3 | |
| Chemosis | 0 | 0 | 0 | 0.0 | ||
| Discharge | 1 | 1 | 1 | 1.0 | ||
| 21 days | Cornea | Opacity | 2 | 1 | 3 | 2.0 |
| Area | 4 | 1 | 4 | 3.0 | ||
| Iris | Value | 1 | 0 | * | 0.3 | |
| Conjunctivae | Redness | 0 | 0 | 0 | 0.0 | |
| Chemosis | 0 | 0 | 0 | 0.0 | ||
| Discharge | 1 | 0 | 0 | 0.3 | ||
| * Cannot be visualised | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information severe eye irritant Criteria used for interpretation of results: EU
- Conclusions:
- TBHP (aqueous solution as tested) caused severe and irreversible damage to treated eyes in this study. It is a severe eye irritant and it follows that TBHP itself is also a severe eye irritant.
- Executive summary:
TBHP (aqueous solution as tested) caused severe and irreversible damage to treated eyes in this study. Based on the available data, TBHP classification as causing serious eye damage (Category 1) is warranted under EC Regulation 1272/2008, CLP.
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.
