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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (405): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-85-608
- Physical state: liquid
- Analytical purity: assumed 100 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat (assumed 100%)
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Observations at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Driaze

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.83
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.83
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CAS# 98072-31-2 was found to be slightly irritating to the eyes. Effects were reversible within 4 days.
Executive summary:

Discard alcohol (CAS #84852-02-8) is a mixture of components: a mixture of C8-13 branched hydrocarbons, C9-13 branched primary alcohols and C10-12 cyclic ethers. All components are multi-isomeric. The composition is variable. All structures are branched and multi-isomeric. For the purposes of read across, data from an equivalent alcohol will be used (isodecanol, CAS #68526-85-2), as will data from a commercial substance (Vammar D10, CAS #98072-31-2) that contains similar aliphatic ethers to discard alcohol. 

 

Skin

As assessed in dermal irritation studies, CAS # 98072 -31 -2 is transiently irritating to the skin.  In a study utilizing an occluded patch exposure, the presence of erythema was noted within 4 hours of patch removal and remained present until at least seven days post exposure.  The severity of the erythema induced by CAS # 98072 -31 -2 exposure ranged from very slight to severe during this time frame.  However, upon removal, signs of irritation subside. CAS # 98072 -31 -2 is also transiently irritating to the eye as assessed in rabbits.  Redness was noted in all animals up to 24h post exposure and decreased steadily through 14 days post exposure.

 

CAS #68526-85-2 was administered via an occluded patch to 6 rabbits at a dose of 0.5 ml for 4 hours of exposure to assess dermal irritation.  Observations were conducted at 45 minutes, 24, 48 and 72 hours and 7 days after exposure.  Well defined erythema was noted in 1 animal at the 45 minute point while the other animals had very slight erythema. Erythema increased after the 45 minute interval. Five animals were noted with well-defined erythema at the 24 and 48 hour intervals; the mean primary dermal irritation index was 2.16. At the 72 hour interval, all animals were noted with well-defined erythema. Erythema increased again at the Day 7 interval; two animals were noted with severe erythema and four animals were noted with well-defined erythema.  The mean skin irritation scores between 24 and 72 hours were: erythema 1.5 and edema 0.56.

 

Eye

The ocular irritation potential of CAS# 98072-31-2 was evaluated following a single 0.1 ml instillation to the right eye of 6 rabbits.  The treated eyes of all animals remained unwashed.  Observations for signs of ocular irritation and toxicity were made at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7.  Ocular reactions were graded according to the Draize scale for scoring ocular lesions.  Minimal irritation was observed in the animals; responses were limited to the conjunctiva and included redness, chemosis and discharge.  All effects were fully reversible within 7 days post-instillation.  In all but one animal, all effects were fully reversed within 4 days post-instillation.  

 

CAS #68526-85-2 was evaluated for acute eye irritation by a single instillation of 0.1 ml into the left eye of 6 rabbits.  Slight to moderate eye irritation was observed within 1 h post instillation and included slight corneal opacity, slight iritis, and slight to moderate conjunctival redness.  All signs of irritation were resolved by Day 7 post exposure. Mean eye irritation scores between 24 and 72 hours were: cornea score 0.5, iris score 0.5, and conjunctival redness 1.54.