Butyl glycollate

Endpoint summary

Description of key information

The available skin and eye irritation studies with rabbits indicate that butyl glycollate (Polysolvan O) is not irritating to the skin but highly irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation

In a primary dermal irritation study, 3 young adult white rabbits were dermally exposed to 0.5 mL of unchangedbutyl glycollate (96%) for 4 hours under semi-occlusive condition. The animals were observed for up to 7 days. Erythema and edema were not seen at the 30 - 60 min, 24 and 48 h readings. At 72 h only 1/3 rabbit revealed a transient erythema and edema (grade 2 and 1, respectively), which disappeared until day 7. Thus, according tothe EU classification criteria, butyl glycollate (96%) is not considered or classified as a dermal irritant (Kreilingand Jung, 1988a).

Eye irritation

The primary eye irritation potential of butyl glycollate was investigated in three young adult white rabbits. The animals received 0.1 mL of the neat three young adult New Zealand White rabbits for 24 hours. The right eyes served as controls. After 24 hours of exposure, the eyes were washed out with physiological saline solution prior to scoring. The animals were observed for up to 7 days and the readings were performed at 1, 24, 48, 72 hours and 7 days. Irritation was scored according to the scoring scheme of Draize.Various, partly severe signs of ocular irritation were noted in all animals, some of them were not reversible within the 7 day observation period. The mean score for conjunctival erythema was 2.6, conjunctival chemosis was 1.6, iritis was 0.9 and corneal opacity was 1.8. In addition, eye discharge ranging from colorless – white, discolored conjunctivae including bleeding and vascularisation of the cornea of different degree was observed in individual animals at different time points.

Thus, butyl glycollate (96%) was highly irritating to the eyes of the rabbits and asubsequent investigation with butyl glycollate of a very high purity (99.7%) confirmed the severe eye irritating potential (Kreiling, 1994).

Respiratory tract

Within an acute inhalation study to determine the approximate lethal concentration (ALC) four groups of 5 male satellite rats were exposed nose-only for a single, 4-hour period to vapor or aerosol/vapor concentrations of butyl glycollate (99.07%) in air to chamber concentrations of 0.40, 3.0, 4.3, or 6.2 mg/L. All satellite animals were sacrificed approximately 24 hours after exposure, followed by complete gross examination, and representative samples of the nose, pharynx/larynx, and lungs were examined microscopically. No rat died, no clinical signs of toxicity attributable to the test item were observed during the study and no gross abnormalities. Compound-related microscopic findings consisted of irritation in the nose of rats exposed at concentrations of 3.0 mg/L. There were no compound-related microscopic findings in the pharynx/larynx and lungs. The NOEL for upper respiratory tract irritation was 0.40 mg/L (Bamberger JR, 2000).

Effects on eye irritation: highly irritating
Effect level: empty

Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the results of skin irritation and eye irritation studies with rabbits, butyl glycollate (Polysolvan O) has not to be classified as a dermal irritant but has to be classified as Eye Dam. 1 (H318: Causes serious eye damage) according to Regulation (EC) No 1272/2008.