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Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
other: Human observational study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Reference Type:
study report
Title:
Unnamed
Year:
1986
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Study type:
other: Comparison of human experience to eye exposure to surfactants with animal eye irritation studies
Endpoint addressed:
eye irritation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method:Summaries of human manufacturing accident and consumer accident eye irritation incidents over several years were collected for laundry, household and personal cleaning products. These summaries included the date the incident occurred, the exact product or formulation involved, the estimated time for the eyes to return to normal, and a brief description of the eye response. A total of 231 manufacturing employee incidents and 284 consumer incidents were usable, covering 24 and 23 different products, respectively. The results of these human contact incidents were compared to the results of studies conducted using two rabbit eye irritation procedures commonly used to assess eye irritation. These two methods are briefly summarized below:
1. The FHSA (modified Draize) test utilized albino rabbits, which were dosed into the conjunctival sac with 0.1 mL of liquid product or the weight of the solid product equivalent to 0.1 cc. The eyelids were held shut for one second after instillation. The animals were observed at 1, 2, 3, 4, 7, 14 and 21 days or longer.
2. The Griffith low-volume eye irritation test utilized albino rabbits, with the test substances dosed directly on the cornea with 0.01 mL of liquid product or the weight of solids equivalent to 0.01 cc. The eyelid was released immediately after dosing without forced closing. The animals were observed for the same time periods as above.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
C12-LAS
IUPAC Name:
C12-LAS
Details on test material:
C12-LAS

Method

Type of population:
general
occupational
Ethical approval:
not applicable
Details on study design:
Summaries of human manufacturing accident and consumer accident eye irritation incidents over several years were collected for laundry, household and personal cleaning products. These summaries included the date the incident occurred, the exact product or formulation involved, the estimated time for the eyes to return to normal, and a brief description of the eye response. A total of 231 manufacturing employee incidents and 284 consumer incidents were usable, covering 24 and 23 different products, respectively. The results of these human contact incidents were compared to the results of studies conducted using two rabbit eye irritation procedures commonly used to assess eye irritation.

Results and discussion

Results:
Median days-to-clear for human accident eye exposure are minimal. Only one product was as high as 7 days and the rest were 2 days or less. A total of 88.1% of the eyes cleared in 4 days or less. There was no reported permanent eye damage. Both of the animal methods produced more severe eye responses than were reported from human eye accidents with the same consumer products (Freeberg et al. 1984)

Any other information on results incl. tables

Animal studies consistently overestimated the human response to accidentalexposure. Of the two animal methods, the low-volume rabbit test gave acloser correlation, while the FHSAtest gave the least correlation. A followupstudy published in 1986 confirmed this conclusion. Finally, an additionalpaper published in 1995 compared consumer eye irritation comments from1985 to 1992 with the results of low volume eye tests (LVET). The clinicaldata andconsumer experience consistently showed less eye irritation inhumans from exposure to products than was observed in animal studies.Recovery in humans was similar to that reported previously, supportingmilder irritation response and faster healing in humans than in rabbits.

Applicant's summary and conclusion

Conclusions:
Recovery in humans was similar to that reported previously, supporting milder irritation response and faster healing in humans than in rabbits.

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